Job Id —H0028

Job Title —Validation Engineer, at Vastek Inc.

Company —Vastek Inc.

Location —San Diego, California.

Job type —Full-time.

Job Description:

  • • Develop and execute Qualification deliverables for critical utilities systems, including but not limited to Validation Plans, Risk Assessments, IQ/OQ/PQ protocols, Trace Matrices, Test Execution, Summary reports.
  • • Organize and coordinate critical utilities sampling activities for OQ and PQ.
  • • Understanding and experience with regulations and guidelines such as USP and FDA.
  • • Strong knowledge in qualifying clean compressed air, water for Injection (WFI), purified water, and steam.
  • • Strong knowledge of a piping and instrumentation diagram.
  • • A validation lead in planning, tracking, communicating, coordination, and delivery of Validation activities.
  • • Lead validation projects and complete all associated project documentation in line with regulatory expectations.
  • • Manage, coordinate, and guide the execution of the site validation master plan.
  • • Provide the relevant support for regulatory audits, submissions, and another auditor requests.
  • • Populate validation protocols (this requires gaining an in-depth knowledge of the product to be able to determine what the necessary output is and if it is meeting predefined criteria)
  • • Ensure projects are managed in conjunction with all regulatory requirements such as health & safety, cGMP, construction, environmental, etc.
  • • Develop and write commissioning, qualification and validation documents following established standards and templates.
  • • Review design deliverables from engineering including drawings, datasheets, specifications, and engineering lists.

    • Required Qualification & Experience:Vastek requires at least a bachelors degree or higher in an engineering discipline such as industrial engineering, mechanical engineering, Manufacturing engineering, or a closely related field.

    Send resume to attn: Daniella Loza, VAStek, Inc. 1230 Columbia Street, Suite 1180, San Diego, CA 92101(refer to job title).

    Job Id —H0027

    Job Title —Validation Engineer, at Vastek Inc.

    Company —Vastek Inc.

    Location —San Diego, California.

    Job type —Full-time.

    Job Description:

  • • Installing new analytical instruments in QC (Quality Control) laboratory.
  • • Drafting and completing documentation in accordance with GMP (Good Manufacturing Practice) requirements.
  • • Drafting Unit Operations Procedures (UOPs) for new analytical equipment.
  • • Writing instructions for analytical equipment operation.
  • • If necessary, updating Standard Operating Procedures (SOPs) and any controlled forms, SOPs may need updates based on new equipment functionality.
  • • Gathering and managing IQ/OQ (Installation Qualification/Operational Qualification) documentation for instruments and equipment that have been purchased from the vendors.
  • • Ensuring IQ/OQ protocols are reviewed and communicating any comments to the Laboratory Management staff members.
  • • Coordinating and maintaining IQ/OQ activities with the vendors along with timeline and communicating any changes to the Laboratory management staff members.
  • • Completing IQ/OQ documentation requirements as per procedure.
  • • Compiling necessary paperwork for analytical instrumentation and equipment.
  • • In accordance with Bedford procedure, setting up Calibration and Preventive Maintenance (PM) for the instruments and equipment.
  • • Ensuring that equipment has necessary spare parts in inventory.
  • • Ensuring that instruments have annual service agreements in place with the vendor.
  • • Coordinating use of vendor OQ and filling out required documentation.
  • • Performing Performance Qualification (PQ) of instruments and equipment.
  • • As per procedural requirement, for PQ, analyzing standard and/or representative batch to demonstrate instrument’s performance and include collected data in the Equipment Qualification package.
  • • Ensuring that qualification documents are reviewed, and all comments are addressed.

    • Required Qualification & Experience:Only individuals with a bachelors degree or higher in an engineering discipline such as industrial engineeing, mechanical engineering, manufacturing engineering or a closely related field.

    Send resume to attn: Daniella Loza, VAStek, Inc. 1230 Columbia Street, Suite 1180, San Diego, CA 92101(refer to job title).

    Job Id —H0028

    Job Title —NPI Engineer, at Vastek Inc.

    Company —Vastek Inc.

    Location —San Diego, California.

    Job type —Full-time.

    Job Description:

  • • Monitor status of all new products and ensure effective execution of projects according to required policies, procedures and government regulations.
  • • Prepare plans for all NPI projects and coordinate with all stakeholders and ensure good quality products.
  • • Assist Manufacturing department and manage communication across all departments.
  • • Manage material inventory for NPI projects to help eliminate exceptional costs.
  • • Manage the delivery of all Operations activities with the NPI process.
  • • Establish, provide analysis and track progress against agreed upon key business and operating metrics related to new product launches and commercialized products as assigned.
  • • Developing a new product launch process and forms suitable to the business.
  • • Address IVDR needs for new products as well as legacy products.
  • • Responsible for creating a new Device Master Record (DMR) for new SKUs.
  • • Manages an orderly transition from R&D to production/validation and to commercial launch.
  • • Manage product launch projects including partnering with cross functional teams on the integration of New Products into manufacturing with a future look towards lifecycle management, sustaining activities and other Operation responsibilities.
  • • Works closely and collaboratively with the company’s Engineering, QA, Regulatory, Operations and Customer Service personnel to achieve objectives.
  • • Lead Remediation work streams as assigned. Assist team members with remediation milestones and review their work.
  • • Work on updating/remediating manufacturing and Quality procedures, covering gaps between Abbott Global Quality Management System and local procedures.
  • • Perform Training to respective departments (Manufacturing, Operations, Quality Assurance, Quality Control, and Engineering) in new Manufacturing and Quality Procedures.
  • • Monitor remediation milestones of respective work streams and report status updates to management weekly.
  • • Perform other duties & projects as assigned.

    • Required Qualification & Experience:Requires its applicants to have at least a bachelors degree or higher in an engineering discipline such as Industrial Engineering, Mechanical Engineering, Manufacturing Engineering, or a closely related field.

    Send resume to attn: Daniella Loza, VAStek, Inc. 1230 Columbia Street, Suite 1180, San Diego, CA 92101(refer to job title).

    Job Id —H0026

    Job Title —Engineer, at Vastek Inc.

    Company —Vastek Inc.

    Location —San Diego, California.

    Job type —Full-time.

    Job Description:

  • • Create and maintain risk management deliverables (Risk Management Plans/Reports, FMECAs, Post-Market Surveillance Reports, Periodic Safety Update Report, Risk Management Plans/Reports) in compliance to internal and external requirements including new EU MDR requirements.
  • • Support Regulatory Affairs by providing quality input for Clinical Evaluation Reports, Technical Documentation, and notified body submissions.
  • • Participates in corrective/preventive action teams to resolve systemic issues. Partners with cross-functional peers to resolve product performance issues (NCRs, CAPAs, deviations, manufacturing process problems etc.) and to assess impact on device quality and product availability..
  • • Partner with external suppliers to review and assess any design or process changes that may impact the product specifications or overall performance.
  • • Participates in product development process to include design verification, design validation, process validation and other activities as needed.
  • • Designing, writing and support implementing a full validation process and Equipment Qualifications (IQ, OQ, PQ)s.
  • • Developing Master Validation Plan (MVP), Process Failure Mode Effects Analysis (PFMEA), Qualification Documents, Validation Summary Report (VSR) and Requirements Traceability Matrix (RTM).

    • Required Qualification & Experience:Vastek requires its applicants to have at least a bachelors degree or higher in an engineering discipline such as industrial engineering, Mechanical engineering, manufacturing engineering, engineering management, or a closely related filed.

    Send resume to attn: Daniella Loza, VAStek, Inc. 1230 Columbia Street, Suite 1180, San Diego, CA 92101(refer to job title).

    Job Id —H0025

    Job Title —Quality Engineer, at Vastek Inc.

    Company —Vastek Inc.

    Location —San Diego, California.

    Job type —Full-time.

    Job Description:

  • • Supports and maintains the quality system and is able to make quality system recommendations and follow through to implementation to address issues found (CAPA, NCR).
  • • Specifically, this includes:Initiating and evaluating non conformances and CAPAs Performing failure investigations to identify assignable cause and route cause Create action plans to address identified route causes
  • • Work with other departments to resolve issues related to material and process quality, including FMEA, DOE.
  • • Specifically, this includes:Update FMEAs to align with actual occurrence. Performing periodic reviews to FMEAs.
  • • Design experiments to identify risk residual methods.
  • • Suggests recommendations on quality concerns, trends, and costs.
  • • Specifically, this includes: Creating metrics for product defect types and escalate to management if there is a negative trend.
  • • Ability to manage the customer complaint system. Performs analysis of customer complaints..
  • • corrective action requests on discrepant product/processes and verify the adequacy and accuracy of corrective action taken internally and/or externally.
  • • Specifically, this includes: Determine if a complaint needs to be notified to regulatory bodies such and FDA, ANVISA, MHRA based on criticality of complaint.
  • • Perform investigation on c complaints to determine the roots cause and execute corrections and corrective actions as necessary.
  • • Follow up on CAR effectiveness.
  • • Specifically, this includes: Performingn effectiveness monitoring for corrective actions made to Quality system procedures and process. Which includes creating effectiveness monitoring plans, documenting appropriate rationale for sample based on change type and its effect on product, collecting sample data.
  • • Schedules and conducts and/or coordinates internal and external audits; prepares and issues summarized reports; maintains quality surveillance of suppliers. Interface with supplier quality representatives concerning problems with quality and assure that effective corrective action is implemented.
  • • Specifically, this includes: Coordinate with compliance management to create audit schedule for both internal & external audits.c
  • • Escalating the observations issued by external bodies to appropriate management levels per Audit procedures.
  • • Working with subject matters experts to updates procedures per the corrective action plans.

    • Required Qualification & Experience:Minimum to have at least a bachelors degree or higher in an engineering discipline such as industrial engineering, Mechanical Engineering, Manufacturing engineering, Engineering Management, or a closely related field.

    Send resume to attn: Daniella Loza, VAStek, Inc. 1230 Columbia Street, Suite 1180, San Diego, CA 92101(refer to job title).

    Job Id —H0024

    Job Title —Validation Engineer, at Vastek Inc.

    Company —Vastek Inc.

    Location —San Diego, California.

    Job type —Full-time.

    Job Description:

  • • Manage validation documentation, commissioning test scripts, qualification validation protocols, summary reports and risk assessments.
  • • Review design deliverables from engineering including drawings, datasheets, specifications and engineering lists.
  • • Maintain validation documentation through the validation lifecycle.
  • • Provide evidence of both internal and external regulatory compliance.
  • • Troubleshoot in the event of abnormal testing results.
  • • Troubleshoot issues identified by other staff members.
  • • Ensure accurate records of all validation activities
  • • Lead validation projects and complete all associated project documentation in line with regulatory expectations
  • • Support validation projects as needed
  • • Manage, coordinate and guide the execution of the site validation master plan
  • • Provide the relevant support for regulatory audits, submissions and other auditor requests
  • • Populate validation protocols (this requires gaining an in-depth knowledge of the product to be able to determine what the necessary output is and if it is meeting predefined criteria)
  • • Develop and run test protocols
  • • Ensure projects are managed in conjunction with all regulatory requirements such as health & safety, cGMP, construction, environmental, etc
  • • Develop and write commissioning, qualification and validation documents following established standards and templates.
  • • Ensure the validation status of equipment and systems are in compliance with cGMPs at all times.

    • Required Qualification & Experience:Requires its applicants to have at least a bachelors degree or higher in an engineering discipline such as industrial engineering, Mechanical Engineering, Manufacturing Engineering, or a closely related field.

    Send resume to attn: Daniella Loza, VAStek, Inc. 1230 Columbia Street, Suite 1180, San Diego, CA 92101(refer to job title).

    Job Id —H0022

    Job Title —Quality Engineer, at Vastek Inc.

    Company —Vastek Inc.

    Location —San Diego, California.

    Job type —Full-time.

    Job Description:

  • • Perform Sustaining Quality Engineering activities for EU MDR Compliance of Orthopedic Products.
  • • Provide guidance to the Sustaining cross functional teams to ensure compliance to the company’s quality system and external standards.
  • • Perform Gap Assessments by assessing current DHF documentation against EU MDR requirements, review & approve new and updated design control documents.
  • • Determine Critical Quality Attributes for PPAPs.
  • • Product Drawing Change Planning and Assessment for GD&T Drawing updates.
  • • Follow Good Documentation Practice as per company regulations.

    • Required Qualification & Experience:Requires at least a Bachelors degree or higher in an engineering discipline such as industrial engineering, mechanical engineering, chemical engineering, engineering management, manufacturing engineering, or a closely related field.

    Send resume to attn: Daniella Loza, VAStek, Inc. 1230 Columbia Street, Suite 1180, San Diego, CA 92101(refer to job title).

    Job Id —GC001

    Job Title —Validation Engineer, at Vastek Inc.

    Company —Vastek Inc.

    Location —San Diego, California.

    Job type —Full-time.

    Job Description:(VAStek, Inc. has opening in San Diego, CA)Provide technical expertise to define approaches and execution of system validation activities in accordance with applicable regulations, procedures, and industry guidance such as: cGMP, cGXP, CFR 21 Parts 11, 210, and 211, EU Annex 11, ICH Q7, Q8 and Q9. Develop verification/qualification deliveries including but not limited to Requirement Documents, Functional and Design Specifications, quality standard operating procedures, Test Protocols (Installation Qualification/Operation Qualification/ Performance Qualification), and Summary Reports of critical manufacturing equipment, facilities, and utility systems. Execution of Test Protocols including the identification and resolution of non-conformance/deviations. Develop change control activities for equipment and create various manufacturing processes and ensure proper justification of statistical analysis and hypothesis testing. Generate risk management deliverables such as System Impact Assessments, Criticality Assessments, Preliminary Hazard Analysis Assessments and Risk Management Reports. Execute equipment, facility, utility, computer system, and Automated Control validation studies to include protocol preparation, scheduling, protocol execution, analyze data and compose a final report. Conducts Validation deviations and/or participates in deviation investigations to identify root causes and define corrective and/or preventative actions (CAPA). Will work in unanticipated locations.

    Required Qualification & Experience:Requires Bachelors in Industrial Engineering, Mechanical Engineering, Electrical Engineering, Manufacturing Engineering, Engineering Management or closely related field and 3 years’ experience in Manufacturing Equipment Qualification field or Masters in Industrial Engineering, Mechanical Engineering, Electrical Engineering, Manufacturing Engineering, Engineering Management or closely related field and 1 year experience in Manufacturing Equipment Qualification field. 1 year of experience is required in (1) working in an FDA regulated industry with following 21 CFR Part (11, 210, 211, 820, 54), GAMP 5, Annex 11 and e-record/e-signature standards, (2) project management practices, (3) software validation and verification practices, (4) utilization of risk-based approach to validation testing. Employer will accept coursework in place of experience requirements.

    Send resume to attn: Daniella Loza, VAStek, Inc. 1230 Columbia Street, Suite 1180, San Diego, CA 92101(refer to job title).

    Job Id —GC002

    Job Title —Senior Quality Engineer, at Vastek Inc.

    Company —Vastek Inc.

    Location —San Diego, California.

    Job type —Full-time.

    Job Description:(VAStek, Inc. has opening in San Diego, CA)Analyze and design fixtures, processes and recommend automation of process including new equipment and tooling to improve manufacturing methods and improve quality. Perform workflow analysis and layout facility to maximize safety, output, quality and profitability. Develop work instructions for production processes and analyze work force utilization, space requirements, workflow, and designs layout of equipment and workspace for maximum efficiency. Confer with planning and design staff concerning product design and tooling to ensure efficient production methods. Apply statistical methods to conduct system capability studies, estimate future manufacturing requirements and potential. Analyze operating data and statistics to identify opportunities, develop action plans, and implement process improvements. Develop, support, and continually improve DFM/DFT processes to ensure our products are optimized for manufacturing in terms of efficiency, reliability and accuracy in PCBA production, unit assembly, calibration, and testing. Perform a full life cycle product development (design, develop, test prototypes). Conduct design verification test to meet product requirements and specifications. Perform detailed Root Cause Investigation of failed products or processes using various quality tools (5 Whys, 6 M, Ishikawa Diagram, Pareto Charts). Design and execute measurement system analysis on new and existing equipment. Perform necessary calculations, testing and full analysis of data to ensure design and process meets functional and performance specifications. Modify/Update internal specifications to match manufactured goods and reconcile with supplier specifications. Develop, coordinate and conduct technical reliability studies and evaluations of engineering design concepts and design of experiments (DOE) constructs. Recommend design or test methods and statistical process control procedures for achieving required levels of product reliability. Develop and execute IQ / OQ / PQ protocols for the equipment and processes above, and in accordance with regulatory guidelines and cGMP’s. Utilize Lean six sigma principles to maximize the efficiency of equipment applications, including equipment placement. Establish or coordinate the maintenance or safety procedures, calibration, preventive maintenance schedule to maintain machines or equipment in the prescribed condition. Design or specify inspection and testing mechanisms and equipment; conduct quality assurance tests; and perform statistical analysis to assess the cost of and determine the responsibility for products or materials that do not meet required standards and specifications. Ensure that corrective measures meet acceptable reliability standards and that documentation is compliant with requirements. Specialize in the areas of design, incoming material, production control, product evaluation and reliability, inventory control and/or research and development as they apply to product or process quality. Will work in unanticipated locations.

    Required Qualification & Experience:Requires Bachelors in Mechanical Engineering or related and 1 year experience. 1 year must include experience 1) in a regulated engineering industry using quality systems and CAPA, 2) with medical device regulations and standards (21 CFR §820, ISO § 14971 and § 13485) and 3) performing data query and statistical analysis using software tool Minitab.

    Send resume to attn: Daniella Loza, VAStek, Inc. 1230 Columbia Street, Suite 1180, San Diego, CA 92101(refer to job title).

    Job Id —GC003

    Job Title —Process Engineer Specialist, at Vastek Inc.

    Company —Vastek Inc.

    Location —San Diego, California.

    Job type —Full-time.

    Job Description: (VAStek, Inc. has opening in San Diego, CA)Process Engineer Specialist:Install and manage pH sensor production. Assess process capabilities, prioritize process improvements opportunities, and innovate and implement process improvements on multiple and moderately complex processes. Prepares and presents technical data and recommendations at technical reviews. Write and execute validation protocols and report applicable to new/improved processes. Ensure proper documentation is completed to meet quality system requirements. Provide ongoing production support for pH ammonia processes including equipment and process troubleshooting, nonconformance investigation, process change assessments, and process improvements. Implement corrective and preventative actions to ensure compliance with procedures and regulatory requirements. Will work in unanticipated locations.

    Required Qualification & Experience:Requires Masters in Mechanical/Optical/Electrical/ or Biomedical Engineering.

    Send resume to attn: Daniella Loza, VAStek, Inc. 1230 Columbia Street, Suite 1180, San Diego, CA 92101(refer to job title).

    Job Id —H0017

    Job Title —Quality Engineer, at Vastek Inc.

    Company —Vastek Inc.

    Location —San Diego, California.

    Job type —Full-time.

    Job Description:

  • • Ensures that suppliers deliver quality parts, materials, and services. Qualifies suppliers/Contract Manufacturers according to company standards and may administer a Certified Supplier Program in receiving inspection to ensure cost effectiveness Monitors parts from acquisition through the manufacturing cycle and communicates and resolves supplier related problems as they occur.
  • • Develops and prioritizes an auditing schedule to ensure that designated suppliers are audited on a regular basis to ensure good manufacturing practices (GMP) and quality standards are met.
  • • Evaluates suppliers' internal functions to assess their overall performance and provides feedback in assessment of their operation.
  • • Delivers and/or manages projects assigned and works with other stakeholders to achieve desired results. May act as a mentor to colleagues or may direct the work of other lower level professionals.
  • • Delivering and overseeing the projects from design to implementation while and adhering to policies, using specialized knowledge and skills normally acquired through advanced education (typically University).
  • • Recognized expert, managing large projects or processes. Exercises considerable latitude in determining deliverables of assignments, with limited oversight from manager. Coaches, reviews, and delegates work to lower level specialists.
  • • Problems and issues faced are difficult, moderately complex, and undefined, and require detailed information gathering, analysis and investigation.
  • • Direct team members to collaborate in product development cycle by contributing to and reviewing project documentation, product requirement reviews, product risk assessments, and verification and validation testing.
  • • Develops solutions to moderately complex problems, and/or makes moderate to significant improvements of processes, systems, or products independently to enhance performance of job area. Implements solutions to problems.
  • • Represents organization as a primary contact for specific projects and initiatives; communicates with internal and external customers and vendors at various levels. May negotiate with others to reach understanding or agreement, and influence decision making.
  • • Typically provides guidance, coaching and training to other employees within job area. Typically manages major / moderately complex projects, involving delegation of work and review of work products, at times acting as a team leader.
  • • Overall Responsibilities: Overall, this position requires mastery of a specialty area and full knowledge of industry practices, typically obtained through advanced education combined with experience. May have broad knowledge of project management.

    • Required Qualification & Experience:Requires a minimum of a Bachelors degree or higher in an engineering discipline such as Industrial engineering,Mechanical Engineering, Manufacturing engineering, or a closely related field.

    Send resume to attn: Daniella Loza, VAStek, Inc. 1230 Columbia Street, Suite 1180, San Diego, CA 92101(refer to job title).

    Job Id —H0018

    Job Title —Prin Supplier Quality Engineer , at Vastek Inc.

    Company —Vastek Inc.

    Location —San Diego, California.

    Job type —Full-time.

    Job Description: Responsibilities may include the following and other duties may be assigned. Ensures that suppliers deliver quality parts, materials, and services. Qualifies suppliers/Contract Manufacturers according to company standards and may administer a Certified Supplier Program in receiving inspection to ensure cost effectiveness. Monitors parts from acquisition through the manufacturing cycle and communicates and resolves supplier related problems as they occur. Develops and prioritizes an auditing schedule to ensure that designated suppliers are audited on a regular basis to ensure good manufacturing practices (GMP) and quality standards are met. Evaluates suppliers' internal functions to assess their overall performance and provides feedback in assessment of their operation.

    SPECIALIST CAREER STREAM: Typically, an individual contributor with responsibility in a professional discipline or specialty. Delivers and/or manages projects assigned and works with other stakeholders to achieve desired results. May act as a mentor to colleagues or may direct the work of other lower level professionals. The majority of time is spent delivering and overseeing the projects from design to implementation while and adhering to policies, using specialized knowledge and skills normally acquired through advanced education (typically University).

    DIFFERENTIATING FACTORS Autonomy: Recognized expert, managing large projects or processes. Exercises considerable latitude in determining deliverables of assignments, with limited oversight from manager. Coaches, reviews, and delegates work to lower level specialists.

    Organizational Impact: Contributes to defining the direction for new products, processes, standards, or operational plans based on business strategy with a significant impact on work group results. May manage large projects or processes that span outside of immediate job area.

    Innovation and Complexity:Problems and issues faced are difficult, moderately complex and undefined, and require detailed information gathering, analysis and investigation. Develops solutions to moderately complex problems, and/or makes moderate to significant improvements of processes, systems, or products independently to enhance performance of job area. Implements solutions to problems.

    Communication and Influence:Represents organization as a primary contact for specific projects and initiatives; communicates with internal and external customers and vendors at various levels. May negotiate with others to reach understanding or agreement, and influence decision making.

    Leadership and Talent Management: Typically provides guidance, coaching and training to other employees within job area. Typically manages major / moderately complex projects, involving delegation of work and review of work products, at times acting as a team leader.

    Required Qualification & Experience: Requires mastery of a specialty area and full knowledge of industry practices, typically obtained through advanced education combined with experience. May have broad knowledge of project management. Requires a University Degree and minimum 7 years of relevant experience, or advanced degree with a minimum of 5 years of relevant experience. The Prin Supplier Quality Engineer position with our company is one that requires the theoretical and practical application of a body of highly specialized knowledge and which requires the attainment of a bachelor's degree in an engineering discipline such as industrial engineering, mechanical engineering, manufacturing engineering, or a closely related field.

    Send resume to attn: Daniella Loza, VAStek, Inc. 1230 Columbia Street, Suite 1180, San Diego, CA 92101(refer to job title).

    Job Id —H0019

    Job Title —Business and System Analyst, at Vastek Inc.

    Company —Vastek Inc.

    Location —San Diego, California.

    Job type —Full-time.

    Job Description:

  • • Define initial conceptual design and requirements associated with MSP and Mortgage Servicing Initiatives, within the KeyBank standard project management/business analysis lifecycle.
  • • Participate in data mapping and data quality initiatives to make platforms more efficient and accurate.
  • • channel requirements are gathered, mapping sessions complete and the corresponding MSP services are complete, then the intermediate layers like OBP and datapower.
  • • Identify, assess, and document business requirements, functional specifications and Impact Matrix documents for any new or changes to existing applications, recommending business priorities, providing technical expertise, and advising business on options, risks, and costs versus benefits of various solutions.
  • • Build relationships within functional teams across KeyBank.
  • • Work with technology teams and business end-users (Client Service Managers, Product Managers, Regional Business Managers, etc.) as appropriate to meet the objective and deadlines at hand.
  • • Analyze impacts of proposed solutions on technology platforms.
  • • Develop use-cases to explain / demonstrate business requirements / specification to IT team.
  • • Define data quality plans to address data quality issues; work with business partners to build business understanding of data issue.
  • • Partner with the development team and the Quality Assurance team to ensure understanding of the requirements and have sufficient test conditions.

    • Required Qualification & Experience: At least a bachelors degree or higher in Computer Science, a relevant technical engineering discipline (such as software engineering, electronic engineering, or communications engineering), information systems or a closely related field.

    Send resume to attn: Daniella Loza, VAStek, Inc. 1230 Columbia Street, Suite 1180, San Diego, CA 92101(refer to job title).

    Job Id —H0020

    Job Title —Process Engineer, at Vastek Inc.

    Company —Vastek Inc.

    Location —San Diego, California.

    Job type —Full-time.

    Job Description:

  • • Work effectively in highly cross-functional project teams and work independently to accomplish project goals.
  • • Take leadership of validation strategies on new process equipment, with timely implementation by working with resource planning.
  • • Organize interdisciplinary team meetings to plan the utilization of resources and define a project schedule and establish the scope of the validation project. Engage with equipment suppliers from Design through Site Acceptance phases of projects by assisting with document development, review and summary reports. Provide on-site support during machine installation/operational qualification and process characterization to verify design specifications are met.
  • • Follow established procedures to perform and lead improvement initiatives for detailed, accurate, and compliant engineering documentation for Master Validation Plans. pFMEA, Equipment Installation, Test Melhod Validation, Characterization, Process QuaHfication and Process Validation.
  • • Review, edit, approve development documents such as material specifications, machine drawings, Process & Instrumentation Diagrams (P&IDs), and Engineering Protocols/Reports/Datasheets.
  • • Update - Test Procedures, Process Control Documents, Material Acceptance Forms, and Fabrication Procedures when required.
  • • Identify and Drive opportunities to improve the quality system as it relates to design control deliverables including Risk Management documents.
  • • Reviews performance of machinery, equipment, and manufacturing processes to verify their efficiency and investigate and initiate corrective actions to prevent problems and ensure product quality.
  • • Develops manufacturing processes that are applicable to statistical process control and may develop those techniques.

    • Required Qualification & Experience:Requires at least a Bachelors degree or higher in an engineering discipline such as industrial engineering, mechanical engineering, chemical engineering, engineering management, manufacturing engineering, or a closely related field.

    Send resume to attn: Daniella Loza, VAStek, Inc. 1230 Columbia Street, Suite 1180, San Diego, CA 92101(refer to job title).

    Job Id —H0021

    Job Title —Quality Engineer, at Vastek Inc.

    Company —Vastek Inc.

    Location —San Diego, California.

    Job type —Full-time.

    Job Description:

  • • Design and execute the process/ equipment validations critical to new product development, for current and future commercialization of the Product as per FDA's 21CFR part 11 regulations.
  • • Assist with implementation of Quality Design review of product generated revision documentation such as Validation Plans, Test Plans, Risk Assessments, Qualification Protocols (Internal & External) (IQ/OQ), Test Summary reports, Validation Reports, PFMEAs / Process Risk Assessments, Traceability Matrix, Master Documentation Lists are implemented at manufacturing site.
  • • Perform corrective and preventative actions to improve the products in production life cycle at manufacturing site. Lead formal failure analysis and issue resolution activities to ensure preventative action is accomplished.
  • • Assist with the resolution and completion of nonconformance issues of the products raised during the on-going production at the manufacturing plant.
  • • Collaborate with Manufacturing and R&D to support instrumented products for design and process improvements, production transfers, and monitor measurable improvements. Routinely interacts with multifunctional groups.
  • • Provide guidance to engineering regarding design concepts and specification requirements to best utilize equipment and manufacturing techniques. Ensures processes and procedures are in compliance with regulations.
  • • Review and update validation master plans (VMP) and PFMEA to the current standards and product drawing requirements.
  • • Execute Process Hazard Analysis, Failure Mode and Effects Analysis, Root Cause Analysis, and Job Hazard Analysis to ensure full proof of safety and verification at the development stage of the product manufacturing.
  • • Assist with executing change control documentation such as Change Request Form (CRF's), Change Control Implementation Plan, Change Control Summary Report and initiating change controls following new engineering change operations for improvement of new and existing products.
  • • Review and approve Process Flows, Control Plans, Inspection Plans, Material Certifications, in accordance with product design requirements. Support the designing, prototyping, and development of products according to the company's design-control strategy.
  • • Improve manufacturing processes of the product lines by defining, measuring, analyzing, and implementing technical solutions; applying knowledge of statistics, materials science, product design, and fabrication, assembly, tooling, and materials; conferring with equipment vendors.

    • Required Qualification & Experience:This role requires candidate to have at least a bachelor's Degree or Higher in Chemical Engineering or equivalent.

    Send resume to attn: Daniella Loza, VAStek, Inc. 1230 Columbia Street, Suite 1180, San Diego, CA 92101(refer to job title).

    Job Title —Mechanical Engineer, at Vastek Inc.

    Company —Vastek Inc.

    Location —San Diego, California.

    Job type —Full-time.

    Job Description:

  • • Coordinate project recommendations and work with our full-service team of Architects, Engineers.
  • • Serve as Project Engineer for work involving Mechanical (HVAC controls) and Plumbing systems.
  • • Apply skills to prepare and direct construction documentation, studies, and other critical reports.
  • • Developing project documents such as calculations, reports and construction drawings and specifications, for clients, according to regulatory and industry standards.
  • • Perform energy calculations using Energy Pro software to ensure the buildings comply with Title 24 code.
  • • Prepare energy analysis reports based on Title 24 energy calculations.
  • • Coordinating with other disciplines and other internal and external team members (e.g. vendors, clients, and contractors).
  • • Assisting with design development and coordinating with the design team at the direction of the Lead Mechanical Engineer.
  • • Developing Mechanical / Utility equipment and construction specifications.
  • • Developing temperature / humidity control calculations, airflow diagrams, pressurization plans, and classification plans.
  • • Using Revit for sizing and developing layouts for ductwork and piping plans and meeting with architects to authenticate and finalize the designs.

    • Required Knowledge and Experience:Bachelors Required or Masters’ degree (preferred) in Mechanical Engineering from an accredited university

    Send resume to attn: Daniella Loza, VAStek, Inc. 1230 Columbia Street, Suite 1180, San Diego, CA 92101(refer to job title).

    Job Title —Validation Engineer, at Vastek Inc.

    Company —Vastek Inc.

    Location —San Diego, California.

    Job type —Full-time.

    Job Description:

  • • Collecting product specific requirements provided by the product manager using TestTrack client© ensuring all the requirements are recorded before testing.
  • • Co-ordinate with the development team to identify and capture test cases, creating test cases in TestTrack client© covering all the scenarios which the user might encounter while using product developed based upon requirements.
  • • Executing and running all the test cases created in TestTrack client in different environments before going into production to ensure that the product works as specified.
  • • Report issues through a formal bug tracking system as well as work with the development team to help isolate debug resolve issues/bugs so they don’t end up in production.
  • • Responsible for creating validation plans that adheres to BioTel and Quality guidelines as per FDA requirements.
  • • Create all the Quality Approval documentation i.e. Functional Requirements Specifications, System Release Document, Verification and Validation test plans, 21 CFR Part 11 checklist required for the Quality Approval before the release of product.
  • • Ensuring regulatory compliance in validation process with FDA 21 CFR part 11, QSR and ISO 13485 regulatory requirements.
  • • Understanding the design and Implementation of the functional components of a new or revised product, program and process.
  • • Determining risk analysis to identify the potential risk and its severity prioritizing them to test to avert the possible vulnerability to the system.
  • • Ensuring regulatory compliance in validation processes with FDA 21 CFR Part 11, QSR and ISO 13485 regulatory requirements
  • • Ensuring the team has well understood “definition of done” for sprint backlog, Partnering with Scrum Master to drive continuous improvement within the Agile team

    • Required Knowledge and Experience:Requires its applicants to have at least a bachelors degree or higher in an engineering discipline such as industrial engineering , mechanical engineering, Manufacturing Engineering, or a closely related field.

    Send resume to attn: Daniella Loza, VAStek, Inc. 1230 Columbia Street, Suite 1180, San Diego, CA 92101(refer to job title).

    Job Title —Validation Engineer, at Vastek Inc.

    Company —Vastek Inc.

    Location —San Diego, California.

    Job type —Full-time.

    Job Description:

  • • Development of design controls and DHF files, including FMEAs and research reports to remediate combination products that were filed as a drug and have no Design History File for the device constituent part.
  • • Develop Technical Studies, Risk Analysis, Process Mapping, DOE's, Gap Analysis, Statistical Rationales, Discrepancy Reports, among other documentation.
  • • Responsible for Customer Complaint Investigations, Pre and Post market summary reports and Continuous Improvement projects, and Quality Systems Excellence among other projects.
  • • Work on revisions of uFMEA, DFMEA and pFMEA by effectively capturing user needs, design constraints, process inefficiencies and Hazard Analysis to ensure full proof safety
  • • Assist in investigations associated with Out-of-Specification (OOS) and Non-conforming material reports (NCMR), Deviations, CAPA and Supplier Corrective Action Reports (SCARs).
  • • Author Project Initiation Document (PID), User Requirement Specifications (URS), and Product Requirement Specifications (PRS) documents.
  • • Apply quality engineering practices and guidance to support project team operations using Six Sigma tools, FMEA, Cause & Effect Matrix, DOE and Control Plans.
  • • Develop and update the Trace Matrix to track requirements to ensure compliance with FDA regulations and quality review.
  • • Review and approve all the quality documents, quality procedures and Standard Operating Procedures (SOP’s).
  • • Independently provide comprehensive technical solutions for issues related to quality processes, procedures and systems to meet organizational and regulatory objectives.
  • • Utilize statistical methods, such as, process capability data analysis, statistical process control (SPC), sample size and frequency selection to ensure processes capability and repeatability.
  • • Work in collaboration with sister-sites and suppliers to get the information needed to author the required DHF documents.

    • Required Knowledge and Experience:Minimum Requirement of a Bachelors Degreeor higher in an Engineering Discipline such as Industrial Engineering, Mechanical Engineering, electrical engineering, Manufacturing Engineering or a closely related field.

    Send resume to attn: Daniella Loza, VAStek, Inc. 1230 Columbia Street, Suite 1180, San Diego, CA 92101(refer to job title).

    Job Title —Business Analyst, at Vastek Inc.

    Company —Vastek Inc.

    Location —San Diego, California.

    Job type —Full-time.

    Job Description:

  • • Participate in development and review of all of the artifacts such as Business Requirement document, functional specifications, and QA test plan.
  • • Elicit business requirements, and interpret them into practical technical solutions
  • • Interact and coordinate with system developers and business subject matter experts on application changes, development, and deployment
  • • Create and maintain system and user documentation
  • • Provide regular verbal and written reports to management and business community
  • • Participate in systems and processes design and implementation efforts.
  • • Perform other related duties as required and assigned
  • • Demonstrate behaviors which are aligned with the organization’s desired culture and values
  • • Must have experience in developing Enterprise level applications using different technology
  • • Ability to interpret XML
  • • Ability to work on multiple Projects
  • • Understanding of Secondary Pricing across investor products/guidelines
  • • Excellent interpersonal and verbal/written communication skills a must
  • • Excellent organizational and analytical skills a must
  • • Correspondent/retail origination Experience
  • • Must be highly proficient in Excel and Word
  • • Must be a team player with strong attention to detail and able to work independently
  • • Proven track record at delivering timely and accurate information in a fast-paced environment
  • • Excellent critical thinking, problem solving, mathematical skills and sound judgment
  • • Financial Services and, if possible, mortgage industry experience preferred
  • • Strong business acumen and ability to interface with executive management

    • Required Knowledge and Experience:Minimum Bachelors degree or Higher in Computer science, a relevant technical engineering discipline

    Send resume to attn: Daniella Loza, VAStek, Inc. 1230 Columbia Street, Suite 1180, San Diego, CA 92101(refer to job title).

    Job Title —Validation Engineer, at Vastek Inc.

    Company —Vastek Inc.

    Location —San Diego, California.

    Job type —Full-time.

    Job Description:Responsibilities may include the following and other duties may be assigned. Ensures that suppliers deliver quality parts, materials, and services. Qualifies suppliers according to company standards and may administer a Certified Supplier Program in receiving inspection to ensure cost effectiveness. Monitors parts from acquisition through the manufacturing cycle and communicates and resolves supplier related problems as they occur. Develops and prioritizes an auditing schedule to ensure that designated suppliers are audited on a regular basis to ensure good manufacturing practices (GMP) and quality standards are met. Evaluates suppliers' internal functions to assess their overall performance and provides feedback in assessment of their operation.

    SPECIALIST CAREER STREAM:Typically, an individual contributor with responsibility in a professional discipline or specialty. Delivers and/or manages projects assigned and works with other stakeholders to achieve desired results. May act as a mentor to colleagues or may direct the work of other lower level professionals. The majority of time is spent delivering and overseeing the projects from design to implementation while and adhering to policies, using specialized knowledge and skills normally acquired through advanced education (typically University).

    DIFFERENTIATING FACTORS AUTONOMY:Seasoned individual contributor. Works independently under limited supervision to determine and develop approach to solutions. Coaches and reviews the work of lower level specialists; may manage projects / processes.

    ORGANIZATIONAL IMPACT:May be responsible for entire projects or processes within job area. Contributes to the completion of work group objectives, through building relationships and consensus to reach agreements on assignments.

    INNOVATION AND COMPLEXITY:Problems and issues faced are difficult, and may require understanding of multiple issues, job areas or specialties. Makes improvements of processes, systems, or products to enhance performance of the job area. Analysis provided is in depth in nature and often provides recommendations on process improvements.

    COMMUNICATION AND INFLUENCE:Communicates with senior internal and external customers and vendors. Exchange information of facts, statuses, ideas, and issues to achieve objective, and influence decision making.

    LEADERSHIP AND TALENT MANAGEMENT: May provide guidance, coaching and training to other employees within job area. May manage projects, requiring delegation of work and review of others' work product.

    Required Knowledge and Experience:Requires advanced knowledge of job area combining breadth and depth, typically obtained through advanced education combined with experience. May have practical knowledge of project management.

    Minimum Requirement of a Bachelors Degreeor higher in an Engineering Discipline such as Industrial Engineering, Mechanical Engineering, electrical engineering, Manufacturing Engineering or a closely related field.

    Send resume to attn: Daniella Loza, VAStek, Inc. 1230 Columbia Street, Suite 1180, San Diego, CA 92101(refer to job title).

    Job Title —Quality Engineer, at Vastek Inc.

    Company —Vastek Inc.

    Location —San Diego, California.

    Job type —Full-time.

    Job Description:

  • 1- Experience in process validation (Installation Qualifications, Operational Qualification and Process Qualifications)
  • 2- Experience with Test Method Validation, Gage R&R
  • 3- Experience with Minitab for statistical analysis
  • 4- Experience with DMAIC and DRM tools
  • 5- Experience with Production Manufacturing, cGMP and FDA CFR 820 Regulations
  • 6- Experience with Class I, II and III Medical device manufacturing
  • 7- Experience with production controls, fixture design and qualifications,
  • 8- Experience with transfer activities such as product line transfers from one site to another
  • 9- Experience with Internal supplier quality controls such as completing Intra quality agreement etc…
  • 10-Experience with addressing non-conformances and basic root cause analysis.

    • Responsibilities may include the following and other duties may be assigned. Develops, modifies, applies and maintains quality standards and protocol for processing materials into partially finished or finished materials product. Collaborates with engineering and manufacturing functions to ensure quality standards are in place. Devises and implements methods and procedures for inspecting, testing and evaluating the precision and accuracy of products and production equipment. Designs or specifies inspection and testing mechanisms and equipment; conducts quality assurance tests; and performs statistical analysis to assess the cost of and determine the responsibility for products or materials that do not meet required standards and specifications. Ensures that corrective measures meet acceptable reliability standards and that documentation is compliant with requirements. May specialize in the areas of design, incoming material, production control, product evaluation and reliability, inventory control and/or research and development as they apply to product or process quality.

    SPECIALIST CAREER STREAM:Typically an individual contributor with responsibility in a professional discipline or specialty. Delivers and/or manages projects assigned and works with other stakeholders to achieve desired results. May act as a mentor to colleagues or may direct the work of other lower level professionals. The majority of time is spent delivering and overseeing the projects from design to implementation while and adhering to policies, using specialized knowledge and skills normally acquired through advanced education (typically University).

    DIFFERENTIATING FACTORS AUTONOMY:Established and productive individual contributor. Works independently with general supervision on larger, moderately complex projects / assignments.

    ORGANIZATIONAL IMPACT: Sets objectives for own job area to meet the objectives of projects and assignments. Contributes to the completion of project milestones . May have some involvement in cross functional assignments. Innovation and Complexity: Problems and issues faced are general, and may require understanding of broader set of issues or other job areas but typically are not complex . Makes adjustments or recommends enhancements in systems and processes to solve problems or improve effectiveness of job area.

    COMMUNICATION AND INFLUENCE:Communicates primarily and frequently with internal contacts . External interactions are less complex or problem solving in nature. Contacts others to share information, status, needs and issues in order to inform, gain input, and support decisionmaking. Leadership and Talent Management: May provide guidance and assistance to entry level professionals and / or employee in Support Career Stream.

    Required Knowledge and Experience:Requires practical knowledge and demonstrated competence within job area typically obtained through advanced education combined with experience. Requires a University Degree and minimum of 2 years of relevant experience, or advanced degree with 0 years of experience.

    Send resume to attn: Daniella Loza, VAStek, Inc. 1230 Columbia Street, Suite 1180, San Diego, CA 92101(refer to job title).

    Job Title —Sr.Manufacturing Engineer, at Vastek Inc.

    Company —Vastek Inc.

    Location —San Diego, California.

    Job type —Full-time.

    Job Description:Responsibilities may include the following and other duties may be assigned. Designs manufacturing processes, procedures and production layouts for assemblies, equipment installation, processing, machining, and material handling. Designs arrangement of machines within plant facilities to ensure most efficient and productive layout. Designs sequence of operations and specifies procedures for the fabrication of tools and equipment and other functions that affect product performance. Adapts machine or equipment design to factory and production conditions. May incorporate inspection and test requirements into the production plan. Inspects performance of machinery, equipment, and tools to verify their efficiency, and investigates and initiates corrective action of problems and deficiencies to ensure product quality. Develops manufacturing processes that are applicable to statistical process control and may develop those techniques. Provides guidance to engineering regarding design concepts and specification requirements to best utilize equipment and manufacturing techniques. Ensures processes and procedures are in compliance with regulations. May be involved in process validation activities (IQ/OQ/PQ).

    SPECIALIST CAREER STREAM:Typically, an individual contributor with responsibility in a professional discipline or specialty. Delivers and/or manages projects assigned and works with other stakeholders to achieve desired results. May act as a mentor to colleagues or may direct the work of other lower level professionals. The majority of time is spent delivering and overseeing the projects from design to implementation while and adhering to policies, using specialized knowledge and skills normally acquired through advanced education (typically University).

    DIFFERENTIATING FACTORS AUTONOMY:Seasoned individual contributor. Works independently under limited supervision to determine and develop approach to solutions. Coaches and reviews the work of lower level specialists; may manage projects / processes. Organizational Impact: May be responsible for entire projects or processes within job area. Contributes to the completion of work group objectives, through building relationships and consensus to reach agreements on assignments. Innovation and Complexity: Problems and issues faced are difficult, and may require understanding of multiple issues, job areas or specialties. Makes improvements of processes, systems, or products to enhance performance of the job area. Analysis provided is in depth in nature and often provides recommendations on process improvements.

    COMMUNICATION AND INFLUENCE:Communicates with senior internal and external customers and vendors. Exchange information of facts, statuses, ideas and issues to achieve objective, and influence decision making. Leadership and Talent Management: May provide guidance, coaching and training to other employees within job area. May manage projects, requiring delegation of work and review of others' work product. Required Knowledge and Experience: Requires advanced knowledge of job area combining breadth and depth, typically obtained through advanced education combined with experience. May have practical knowledge of project management.

    Requires a University Degree and minimum of 4 years of relevant experience, or advanced degree with a minimum of 2 years relevant experience

    Send resume to attn: Daniella Loza, VAStek, Inc. 1230 Columbia Street, Suite 1180, San Diego, CA 92101(refer to job title).

    Job Title —Design control Quality Engineer, at Vastek Inc.

    Company —Vastek Inc.

    Location —San Diego, California.

    Job type —Full-time.

    Job Description:

  • • Write/Review and maintain technical documents such as test protocols, test reports, SOP’s, design verification/validation, engineering specifications, and related information to obtain knowledge of methods, procedures, and activities.
  • • Provide design control engineering tactical expertise to develop TAR-200 and Inserter.
  • • Define document requirements for products, process, and test methods verifications and validations per FDA QSR’s and specific Design Control projects activities.
  • • Develops, modifies, applies and maintains quality standards and protocol for processing materials into partially finished or finished materials product.
  • • Review and approval of Design Control elements, including but not limited to Planning, Device History File(s), Change Control, and associated and supporting documentation.
  • • Monitor testing procedures to ensure that all tests are performed according to established item specifications, standard test methods, or protocols.
  • • Evaluation of component and system-level specifications relative to customer needs and product performance specifications.
  • • Ensure technical integrity of the design control process is met, including content compliance and completeness of the design history file (DHF), collaboratively communicating and resolving gaps, and supporting the transition of the design project into sustaining engineering.
  • • Apply problem-solving and quality improvement tools and techniques, including preventative and corrective actions, and how to overcome barriers to quality improvements.
  • • Acquire and analyze data using appropriate standard quantitative methods to facilitate process analysis and improvements.

    • TECHNICAL SPECIALIST CAREER STREAM:An individual contributor with responsibility in our technical functions to advance existing technology or introduce new technology and therapies. Formulates, delivers and/or manages projects assigned and works with other stakeholders to achieve desired results. May act as a mentor to colleagues. Most of the time is spent delivering R&D, systems, or initiatives related to new technologies or therapies - from design to implementation - while adhering to policies, using specialized knowledge and skills.

    DIFFERENTIATING FACTORS:

    Autonomy:Established and productive individual contributor. Works independently with general supervision on larger, moderately complex projects/ assignments.

    Organizational Impact:Sets objectives for own job area to meet the goals of projects and assignments. Contributes to the completion of project milestones. May have some involvement in cross-functional tasks.

    Innovation and Complexity:Problems and issues faced are general and may require an understanding of a broader set of issues or other job areas but typically are not complicated. Adjusts or recommends enhancements in systems and processes to solve problems or improve the job area's effectiveness.

    Communication and Influence: Communicates primarily and frequently with internal contacts. External interactions are less complex or problem-solving in nature. Contacts others to share information, status, needs, and issues to inform, gain input, and support decision-making.

    Leadership and Talent Management:May provide guidance and assistance to entry-level professionals and / or employee in Support Career Stream.

    Required Knowledge and Experience:Requires practical knowledge and demonstrated competence within the job area typically obtained through advanced education combined with experience.

    The minimum requirement for performance of these duties is a bachelor’s degree in Mechanical engineering or a closely related field.

    EOE. Apply to Fax # 866-849-7714.

    Job Title —Manufacturing Engineer, at Vastek Inc.

    Company —Vastek Inc.

    Location —San Diego, California.

    Job type —Full-time.

    Job Description:

  • • Lead Engineer to support the change management and co-ordination work.
  • • Create project implementation/high level completion plan by coordination with Quality, Planning, Manufacturing & Packaging teams.
  • • Work on Product change management process and coordinate with multiple departments.
  • • Responsible to direct, oversee and update a variety manufacturing processes and documents e.g. Failure Mode Effect Analysis (PFMEA, DFMEA), Route Sheets, create or update technical files such as Process Specification, Material Specification, Control Plans, Test Reports, AQR (Automated Quality Records), Use Ss, 5 Why, Root cause analysis, Kanban etc.
  • • Perform time studies to reduce cycle time, process costs and improve productivity of the manufacturing packaging line.
  • • Create or update Critical Control Plan (CCP), Risk Management Report (RMR), Validation Master Plan (VMP), Training Reports (TRs) for the packaging line as per change in processes.
  • • Write Protocols & Reports of IQ(lnstallation Qualification), OQ (Operation Qualification), PQ (Performance Qualification).
  • • Update BOM (Bill of Materials) and Vision systems as per the process change.
  • • Understand all engineering drawings to figure out accurate artwork numbers, part numbers and packaging assembly details.
  • • Setup the tolerances to each packaging weight scales to accept/reject inspection samples.
  • • Work on GR&R/TMV (Test Method Validation) for each packaging line.
  • • Create protocols & completion reports for Test Method Validations.
  • • Create ECN’s (Engineering Change Notice) to record design, process changes throughout lifecycle phases of a product/processes.
  • • Collaborate with cross-functional teams including Quality, Labeling, Packaging, Regulatory, Project leadership.
  • • Daily, Weekly meeting with Project Leads, Plant Manager & relevant teams for status updates, collecUprovide data.

    • EOE. Apply to Fax # 866-849-7714.

    Job Title —Validation Engineer

    Company —Vastek Inc.

    Location —San Diego, California.

    Job type —Full-time.

    Job Description:

    Vastek, Inc. in San Diego, CA is seeking Validation Engineers to perform validation and develop validation documents for Laboratory instrumentation by following approved Standard Operating Procedures (SOPs, current Good Manufacturing Practices (GMPs), and all other regulatory requirements. Duties and responsibilities will include:

    Responsibilities:

    • Support the Validation Supervisor to ensure effective Validations execution and maintenance of manufacturing equipment, facilities and process utilities.
    • Track and Report action plan status/completion as relates to Validation Systems improvement efforts.
    • Responsible for Developing and Executing Qualifications, Validations, Re-Qualifications and Re-Validations for Process Equipment, Laboratory Equipment, Utilities and Facilities.
    • Generate and Execute Validation Project Plans, Validation protocols (IQ/OQ/PQ), Summary Reports and SOPs as required by Validation Master Plan, SOPs and Global Policies. Systems include Incubators, BSC’s, Autoclaves, Bioreactors, Process Gases, DI Water System, Laboratory Freezers, classified Clean Rooms/HVAC(Grades A through D).
    • Work Independently (Author Protocol, Execute Studies, Analyze Data and Author Reports).
    • Discuss Expectations for Validation Activities, Program and Documentation.
    • Handle some midsize project work but with oversight at a moderate degree.
    • Plan and Organize qualification, validation and verification activities amongst cross functional groups.
    • Provide and Maintain status updates for validation activities related to day to day operations or project work.
    • Assess Change Controls with an accurate understanding of the bigger picture implications of changes, review, oversight and feedback.
    • Generate summary and detailed reports to recapitulate the validation results.
    • Responsible for Validation life cycle, Validation protocols (IQ/OQ/PQ) generation and execution of manufacturing equipment, laboratory equipment, clean process utilities and classified facilities.
    • Work with validated computer systems and change management in the pharmaceutical/ biotech industry, including training others.
    • Ensure GMP compliance, 21 CFR parts 210, 211, 11, GAMP 5 and ISO 13485: 2003 requirements.
    • Handle Kaye Validator and Ellab Data Acquisition Systems including SIM setup, Pre- and Post-calibration of Thermocouples.
    • Perform temperature mapping studies using Kaye validator and Kaye data loggers for Manufacturing & Sterile Supply support equipment.
    • Perform temperature mapping studies using Ellab Data Acquisition System and Ellab Data Loggers for Manufacturing & Sterile Supply support equipment.
    • Analyze and Interpret validation test data to determine whether systems or processes have met validation criteria or to identify root causes of deviations.
    • Generate Deviation reports, Perform root cause investigation and Document Corrective & preventive action (CAPA).
    • Perform Statistical analysis of data and use of on site softwares - Data Management System (DMS), Spreadsheets, Validations Tracker spreadsheet, Fieldglass, Word processing software, SAP, and Trackwise systems.
    • Use Kaye Validator Software and Valsuite Validation & Calibration Software - ELLAB.
    • Use experience and knowledge to solve problems. Seek direction from the department head and make some recommendations for the department.
    • Identify and Respond to day to day problems, interpret data and draw valid conclusions.
    • Improve efficiency of Self and Team by defining, analyzing problems and implementing new ways of approaching work.
    • Manage Day to day tasks, mid size projects, establish department goals, prioritize own work and organizational skills.
    • Write procedures and reports; communicate status, needs and timelines effectively to management; use people skills to resolve or avoid conflict.

    Minimum Requirements:Bachelor's degree or higher in an engineering discipline such as industrial engineering, mechanical engineering, electrical engineering, engineering management, manufacturing engineering, or a closely related field.

    Job Title —Quality Engineer, at Vastek Inc.

    Company —Vastek Inc.

    Location —San Diego, California.

    Job type —Full-time.

    Job Description:

  • • Bachelor’s degree in Engineering or other technical discipline and a minimum of 2 years of related experience.
  • • Master’s degree in engineering or Technical discipline and 0-2 years of related experience

    • Preferred Education and Experience:

  • • Medical Device industry experience preferred along with ASQ-CQE Certification.
  • • Formal Project Management training
  • • Minitab, Statistical Process Control software application experience
  • • Experience in a High-Tech manufacturing environment providing direct process support
  • • 5 years direct Quality experience
  • • Designs gages and fixtures to improve and simplify inspection of products. Conducts gage design reviews with Tooling Team personnel and interfaces with Sourcing personnel, suppliers, and outside gauging suppliers as needed.

    Performs Quality Planning Design reviews for new products and launches which may include preparation of:

  • • PFMEAs
  • • Control Plans
  • • Criteria development
  • • Critical to Quality characteristic identification.
  • • Depositions nonconforming product. Processes associated nonconformance reports (MCDRs), deviation requests (ERBs) and CAPA requests (CARs) accordingly.
  • • Develops IQS criteria and insures that features are properly identified and in agreement with engineering drawings. Approves and initiates associated change requests as required (Memo to File, Engineering Change Order).
  • • Optimizes inspection criteria to improve quality throughout manufacturing and at final inspection while insuring product functionality.
  • • Reviews QC work histories to identify products requiring high inspection times and rejections and reviews so changes to processes or specifications can be identified and improvements made to increase quality and throughput.
  • • Trains Medtronic employees and supplier personnel in specific product requirements and Quality tools and techniques.
  • • Tracks and Trends Quality Data; reviews QC work history to optimize inspection throughput. Generates CAPA requests as required to address systemic problems ascertained via data analysis.
  • • Develops SPC and associated data collection methods.
  • • Recommends and implements improved gauging methods for in-process and final inspection operations.
  • • Responsible for maintaining standardizing and optimizing product inspection procedures.
  • • Specifies and requisitions measuring and gaging equipment as required.
  • • Makes appropriate changes in Gauging and inspection procedures when dictated by engineering drawing changes. Documents all changes through the appropriate control system.
  • • Resolves technical production problems on assigned product lines involving gauging and inspection procedures working with shop employees and suppliers and other team personnel.
  • • Performs technical quality reviews of suppliers to support purchasing personnel certifying suppliers.
  • • Makes recommendations for upgrades, acquisitions and enhancements related to equipment and software to support and improve the quality system.
  • • Travels as required for company business which could be extensive at times. May include visits to supplier facilities, visits to Memphis for meetings, visits to other Medtronic facilities, and travel to training classes or seminars.
  • • Performs supplier audits and source inspection activities as required.
  • • Supports supplier approval process as required.
  • • Utilize PFMEA tools to perform process improvements

    • EOE. Apply to Fax # 866-849-7714.

    Job Title —Test Engineer II, at Vastek Inc.

    Company —Vastek Inc.

    Location —San Diego, California.

    Job type —Full-time.

    Job Description:

  • • Collecting product specific requirements provided by the product manager using TestTrack client© ensuring all the requirements are recorded before testing
  • • Co-ordinate with development team to identify and capture test cases, creating Test cases in TestTrack client© covering all the scenarios which the user might encounter while using product developed based upon requirements
  • • Executing and running all the test cases created in TestTrack client© in different environments before going into production to ensure that the product works as specified
  • • Report issues through a formal bug tracking system as well as work with the development team to help isolate debug resolve issues/bugs so they don't end up in production
  • • Responsible for creating Validation plans that adheres to BioTel and Quality guidelines as per FDA requirement
  • • Collecting objective evidence meeting all the acceptance criteria documented in the validation Plan
  • • Responsible for partnering with Scrum master to analyze and continuously improve validation process within the Agile team
  • • Create all the Quality Approval documentation i.e. Functional Requirement Specification, System Release Document, Verification and Validation test plans, 21 CFR Part 11 checklist required for the Quality Approval before the release of product
  • • Ensuring regulatory compliance in validation process with FDA 21 CFR part 11, QSR and ISO 13485 regulatory requirements
  • • Understanding the design and Implementation of the functional components of a new or revised product, program and process
  • • Determining risk analysis to identify the potential risk and its severity prioritizing them to test to avert the possible vulnerability to the system
  • • Ensuring the team has a well understood "definition of done" for sprint backlog and development and maintenance of regression test suites

    • Required Qulification:Bachelors in Engineering

    EOE. Apply to Fax # 866-849-7714.

    Job Title —Manufacturing engineering, at Vastek Inc.

    Company —Vastek Inc.

    Location —San Diego, California.

    Job type —Full-time.

    Job Description:

  • • Medical Device/Pharma manufacturing engineering experience (1 to any number of years’ experience)
  • • Experience writing/executing validations
  • • Makes improvements of processes, systems, or products to enhance performance of the job area. Analysis provided is in depth in nature and often provides recommendations on process improvements.
  • • Engineering change/documentation experience (any) Responsibilities may include the following and other duties may be assigned. Designs manufacturing processes, procedures and production layouts for assemblies, equipment installation, processing, machining, and material handling. Designs arrangement of machines within plant facilities to ensure most efficient and productive layout. Designs sequence of operations and specifies procedures for the fabrication of tools and equipment and other functions that affect product performance. Adapts machine or equipment design to factory and production conditions. May incorporate inspection and test requirements into the production plan. Inspects performance of machinery, equipment, and tools to verify their efficiency, and investigates and initiates corrective action of problems and deficiencies to ensure product quality. Develops manufacturing processes that are applicable to statistical process control and may develop those techniques. Provides guidance to engineering regarding design concepts and specification requirements to best utilize equipment and manufacturing techniques. Ensures processes and procedures are in compliance with regulations.

    • Communication and Influence:Communicates with senior internal and external customers and vendors. Exchange information of facts, statuses, ideas, and issues to achieve objective, and influence decision making.

    Leadership and Talent Management:May provide guidance, coaching and training to other employees within job area. May manage projects, requiring delegation of work and review of others' work product.

    Required Knowledge and Experience:Requires advanced knowledge of job area combining breadth and depth, typically obtained through advanced education combined with experience. May have practical knowledge of project management. Requires a University Degree and minimum of 4 years of relevant experience, or advanced degree with a minimum of 2 years relevant experience.

    EOE. Apply to Fax # 866-849-7714.

    Job Title —Director of Engineering, at Vastek Inc.

    Company —Vastek Inc.

    Location —San Diego, California.

    Job type —Full-time.

    Job Description:

    (VAStek, Inc. has opening in San Diego, CA) Direct initial program planning including proposal philosophy coordination, technical baseline definition, proposal preparation; subcontractor statements of work specifications; estimation of product or service costs. Establish procedures and assignments to be followed to meet program completion dates as planned; ensure that estimates of manpower needs, costs and budgets are prepared, established and monitored. Review and evaluate progress of subordinate activities including: review job performance of subordinates and personnel assigned to program, ensure assignments are given according to individual capabilities and promotions, transfers, terminations, compensation change are acted upon where warranted. Act as spokesman to customer personnel on engineering capabilities. Support creation of Vastek company proposals by obtaining detailed project information and requirements, structuring and organizing undefined tasks, and creating project plans and estimates. Provide technical leadership in customer meetings as a subject matter expert on system design, test and manufacturing best practices. Manage selection, training, development and performance management for Vastek technical team. Manage the day-to-day business activities of the team to achieve key business objectives and strategies, with an emphasis on growth. Manage geographically dispersed, multi-disciplinary technical teams. Position requires up to 25% domestic and up to 10% international travel.

    Requires Bachelor of Engineering (any field) and 5 years progressive experience OR Masters of Engineering (any field) and 2 years experience. 2 years of experience must include:

  • • Working in a regulated product development environment such as medical devices or pharmaceuticals
  • • industry standards for commissioning, qualification, and operation of facilities and utilities for cGMP manufacturing
  • • working with teams in multiple geographical locations including Southeast Asia
  • • managing cross-functional teams and collaborating across the business

    • Send resume to attn: Daniella Loza, VAStek, Inc. 1230 Columbia Street, Suite 1180, San Diego, CA 92101(refer to job title).

    Job Title —Cleaning Validation Specialist, at Vastek Inc.

    Company —Vastek Inc.

    Location —San Diego, California.

    Job type —Full-time.

    Job Description:

  • • Perform protocol execution of CIP and COP cleaning validation, product process and cleaning continuous verifications
  • • Perform continuous verifications of validated processes and cleaning equipment
  • • Responsible for drafting process and cleaning validation study protocols
  • • Perform GAP analysis of previous executed protocols
  • • Cleaning Validation Strategy using worst-case cleaning approach, risk-based product grouping approach
  • • Review/modify the product-equipment based Cleaning Validation Matrix for entire site based on cleaning-ability, toxicity, potency and solubility
  • • Provide support to the manufacturing, engineering and quality assurance for cleaning and cleaning validation activities
  • • Responsible for generating equipment characterization reports, FMEA studies

    • Requires Bachelor of Engineering

    EOE. Apply to Fax # 866-849-7714.

    Job Title —Manufacturing Engineering Specialist, at Vastek Inc.

    Company —Vastek Inc.

    Location —San Diego, California.

    Job type —Full-time.

    Job Description:

    (VAStek, Inc. has opening in San Diego, CA)Analyze the market demand for different contracting manufacturing engineering personnel. Use analysis of metrics and knowledge of manufacturing engineering principles to determine the suitability and feasibility of specific employees for specific client requirements as well as the suitability of specific projects for fulfillment by company. Will work in unanticipated locations.

    Minimum Requirment: Requires Masters in Industrial Engineering, Manufacturing Engineering, or Industrial Technology

    Send resume to attn: Daniella Loza, VAStek, Inc. 1230 Columbia Street, Suite 1180, San Diego, CA 92101 (refer to job title).

    Job Title —Equipment Validation Engineer

    Job Description:

    Vastek, Inc. in San Diego, CA is seeking Equipment Validation Engineers to perform validation and develop validation documents for Laboratory instrumentation by following approved Standard Operating Procedures (SOPs, current Good Manufacturing Practices (GMPs), and all other regulatory requirements. Duties and responsibilities will include:

    • Responsible for developing and executing the validation plans according to the approved procedures, collation of test results, organize data packages and maintain all documentation pertaining to validation.
    • Comply and analyze validation data, prepare reports, and route documentation.
    • Manage Change Control Management System (CCMS).
    • Investigate and troubleshoot problems that occur during the development and deployment phase and determine the solutions.
    • Perform Periodic reviews and data integrity and security assessments as needed.
    • Coordinate and execute validation change control and preparation of draft protocols, reports, and data tables.
    • Participate in cross-functional project teams with the support of quality and other groups.
    • Contribute directly to the completion of projects through the management of assigned contract personnel, development, and execution of validation change control documents, and development and review of protocols, reports, and data tables generated by peers and contract personnel.
    • Independently apply validation principles to work assignments, review and approve documents and resolve problems.
    • Utilize standalone computerized instruments and software such as HPLC, UPLC, etc.

    THIS POSITION DOES NOT SUPERVISE ANY OTHER PERSONNEL.

    Minimum Requirements:Bachelor’s degree or higher in Business Administration, Information Systems, Management Information Systems, Computer Science, or any related IT field of study, plus at least one (1) year of experience in the job offered or in any related position(s) involving evaluation, validation and/or testing of systems.

    No travel; no telecommuting. Job duties are project-based and performed on long-term assignments at various unanticipated sites within the U.S. which may require relocation at the end of each long-term project.

    Additional Information:

    • Job Site: 1230 Columbia Street, Suite 1180. San Diego, CA 92101.
    • Travel Details (if applicable):No travel; no telecommuting. Job duties are project-based and performed on long-term assignments at various unanticipated sites within the U.S. which may require relocation at the end of each long-term project.
    • Mail Resumes To: Bianca Garcia, HR. 1230 Columbia Street, Suite 1180. San Diego, CA 92101.
    • No calls or emails. EOE.

    Must be legally authorized to work in the United States without sponsorship

    Job Title —Supplier Quality Engineer, at Vastek Inc.

    Company —Vastek Inc.

    Location —San Diego, California.

    Job type —Full-time.

    Job Description:

    Responsibilities may include the following and other duties may be assigned. Ensures that suppliers deliver quality parts, materials, and services. Qualifies suppliers according to company standards and may administer a Certified Supplier Program in receiving inspection to ensure cost effectiveness. Monitors parts from acquisition through the manufacturing cycle and communicates and resolves supplier related problems as they occur. Develops and prioritizes an auditing schedule to ensure that designated suppliers are audited on a regular basis to ensure good manufacturing practices (GMP) and quality standards are met. Evaluates suppliers' internal functions to assess their overall performance and provides feedback in assessment of their operation.

    Specialist Career Stream:Typically an individual contributor with responsibility in a professional discipline or specialty. Delivers and/or manages projects assigned and works with other stakeholders to achieve desired results. May act as a mentor to colleagues or may direct the work of other lower level professionals. The majority of time is spent delivering and overseeing the projects from design to implementation while and adhering to policies, using specialized knowledge and skills normally acquired through advanced education (typically University).

    Differentiating Factors Autonomy:Established and productive individual contributor. Works independently with general supervision on larger, moderately complex projects / assignments. Organizational Impact: Sets objectives for own job area to meet the objectives of projects and assignments. Contributes to the completion of project milestones. May have some involvement in cross functional assignments.

    Innovation and Complexity:Problems and issues faced are general and may require understanding of broader set of issues or other job areas but typically are not complex. Makes adjustments or recommends enhancements in systems and processes to solve problems or improve effectiveness of job area.

    Communication and Influence:Communicates primarily and frequently with internal contacts. External interactions are less complex or problem solving in nature. Contacts others to share information, status, needs and issues in order to inform, gain input, and support decision making.

    Leadership and Talent Management:May provide guidance and assistance to entry level professionals and / or employee in Support Career Stream.

    Required Knowledge and Experience:Requires practical knowledge and demonstrated competence within job area typically obtained through advanced education combined with experience. Requires a University Bachelors or higher in a degree in biotechnology, biology, or a closely related field. and minimum of 2 years of relevant experience.

    EOE. Apply to Fax # 866-849-7714.

    Job Title —Research and Discover Engineer, at Vastek Inc.

    Company —Vastek Inc.

    Location —San Diego, California.

    Job type —Full-time.

    Job Description:

  • • Executing test protocols manually and recording the test results
  • • Creation/ Update of Master Validation Plan and other Validation documents for existing products.
  • • Active participation in the gap analysis, checking for documents in the system and creating new documents for Test Method, Test Method protocols and Validation Reports.
  • • Performing and documenting qualification and validation testing to accommodate process changes for existing product lines.
  • • Facilitating/participating in FMEA’s for existing production processes. Providing Support and implementing preventive actions and control plans to adequately address the FMEA result.
  • • Creation of Data analysis, Technical Reports for reduction of waste and increase in efficiency of the system.

    • Minimum Requirement:

    Bachelor's degree or higher in an engineering discipline such as industrial engineering, mechanical engineering, electrical engineering, engineering management, manufacturing engineering, or a closely related field.

    EOE. Apply to Fax # 866-849-7714.

    Job Title —Essbase Developer, at Vastek Inc.

    Company —Vastek Inc.

    Location —San Diego, California.

    Job type —Full-time.

    (VAStek, Inc. has opening in San Diego, CA) Essbase Developer: Design, develop, maintain and support Financial Reporting Applications. Design end-to-end documentation related to installation and configuration, server maintenance process and application backup and recovery process. Analyze User Requirement Documents, Business Requirement Document (BRD), Technical Requirement Specifications and Functional Requirement Specification (FRS). Design and develop Essbase ASO and BSO cubes to support planning, forecasting and reporting. Involve in development, performance tuning and optimizations for data/dimension loads, Essbase database restricting (BSO/ASO), calculations, and overall Essbase performance. Work with Tableau users in publishing dashboards to the Tableau Server. Maintain security and create/manage users, AD Groups, Licenses and integrate with Active directory. Assist SAS users with troubleshooting and performance tuning models and code. Will work in unanticipated locations.

    Required Knowledge and Experience:Requires Masters in Computer Science, Engineering (any), or Engineering Management and 4 years experience.

    Send resume and refer to job title to attn: Daniella Loza, VAStek, Inc. 1230 Columbia Street, Suite 1180, San Diego, CA 92101.

    Job Title —Data Governance Consultant, at Vastek Inc.

    Company —Vastek Inc.

    Location —San Diego, California.

    Job type —Full-time.

    The Data Governance program ensures that our company can find, understand, access and consume the data we need. As a magistrate of metadata for the Data Governance program, you will facilitate business and technical stakeholders in defining and owning our data assets. You will develop and enrich a data catalog as the authority for information about our data resources. Not only will you mentor our business leadership on their role in data governance, you will lead working groups to asses, define, classify, and steward new data assets, serving as the authority on metadata management. To this end, you will serve as an administrator of the Data Glossary system and ensure that metadata policies are followed and valuable to our company. By leading data governance efforts, you will work with all leaders and decision makers in the company and be a key partner in making data driven decisions in our company.

    Key Responsibilities:

  • • Lead matrix teams for identification, classification, and rationalization of business, technical and operational metadata.
  • • Onboard and train individuals into data governance roles.
  • • Execute standards, policies, and processes regarding metadata management.

    • Skills and Experience:

  • • Bachelor's Degree and/or equivalent combination of education and experience preferred.
  • • 5 or more years of experience in Enterprise Information Management with GAAP or accounting data.
  • • Experience with metadata tools (Collibra, Informatica)
  • • Proficiency in business process requirements gathering and documentation
  • • Demonstrated experience in work estimation and management
  • • Experience with Master Data Management is desired

    • EOE. Apply to Fax # 866-849-7714.

    Job Title —Executive Director, at Vastek Inc.

    Company —Vastek Inc.

    Location —San Diego, California.

    Job type —Full-time.

    Job Description:

    As we continue to grow in the processes it uses to grow it's business and keep up with technological advances, the company has an immediate need for an Executive Director. The Executive Director, hired to work alongside CEO, is primarily responsible for ensuring the mission of VAStek is achieved through heading up the Engineering functions of the organization, creating and maintaining the hiring and training regiments, maintaining client relationships with engineering firms, and reporting weekly to fellow Executives and the Board (as needed) regarding VAStek' s objectives and the pace of achievement. Will be responsible to work within the organization from it's very top and serve as a primary point of contact with leadership at client locations ensuring that all placed engineers are meeting the needs of the client, the primary point of contact with all training personnel to ensure that curricular and training meets the exacting standards of the company, and will oversee and manage all human resources professionals to ensure that hiring of engineers is both sufficient to meet the engineering needs and that the qualifications of the hired professionals are in alignment with existing and proffered contracts.

    The position will be responsible for:Managing Human Resources, Training, and Sales teams, the leadership of whom will report directly to the beneficiary, ensuring the following:

    HUMAN RESOURCES

  • • Making sure that the engineering backgrounds, education, and experience of hired personnel match the needs of engineering clients.
  • • Ensuring that those who recruit at universities, job fairs, etc. are fully conversant in the engineering needs of the company and its clients and are seeking a proper fit for those professionals required.
  • • Ensuring that the professionals hired who may need nonimmigrant visas have experience and education which fit their roles in the company.
  • • Manage teams of engineers by ensuring adequate placement of engineering professionals with firm clients.

    • TRAINING

  • • Ensure that the training personnel are correctly implementing the curricula enabling them to demonstrate the use and design of medical diagnostic and clinical instrumental ion, equipment, and procedures, using the principles of engineering and biobehavioral sciences.
  • • Ensure that the training personnel are fully certified as required and that the certification meets the exacting standards of Vastek and Vastek clients, as well as any regulatory requirements.
  • • Conduct periodic reviews of training manuals and curricula to ensure that they meet existing engineering requirements and protocols.
  • • Ensure that Vastek conducts training or in-services to educate fi rm employees on proper use, development, and maintenance of equipment.

    • SALES

  • • Ensure that sales professionals are fully conversant in engineering terms and fields, adapting as needed with the times, so that they can communicate effectively with engineering clients.
  • • Ensure that contracts proffered by sales professionals are for engineering services that Vastek is equipped to provide and that Vastek employees are available and adequately trained/educated to serve the customers' needs.
  • • Respond, as needed, to specific engineering needs brought by sales personnel or clients, ensuring that Vastek provide the engineering services required.

    • For each of these duties, the Executive Director will also have duties to report to myself as CEO and senior management at Executive and Board level, as needed. For this, the reports will vary from engineering specific to broader " big picture" analysis of the relevant programs and the seamless nature of Vastek operations.

    This position, essential to the company’s corporate vision, relationships with important partners and client s, and to the ability of Vastek to grow, contains the type of highly specialized engineering analysis and understanding of global engineering needs that candidates are expected to have learned in the University setting.

    Minimum Requirement: Masters's in Engineering

    EOE. Apply to Fax # 866-849-7714.

    Job Title —Design engineer

    Company —Vastek Inc.

    Location —San Diego, California.

    Job type —Full-time.

    Job Description:

    Responsible for the design, modeling, development and testing of a machine, structure or system. Develops functional requirements. Understands and applies standard engineering principles. Creates simulations and prototypes to evaluate preliminary designs and test how a machine, structure or system operates. Designs and tests components and integrates components to produce final product. Monitors quality of products and controls the efficiency of processes. Evaluates a design’s overall effectiveness, cost, reliability, and safety. Investigates root causes of failures to maintain quality and recommend improvements.

    Responsibilities –

    • Develops system level design strategies and may lead design, development, testing & refinement of components and sub-systems.
    • Development follows Invent It, Make It, Sell It procedures.
    • Reports observations/problems clearly and concisely, recognizing and highlighting specific deviations and presents possible solutions.
    • Possesses and applies a broad knowledge of principles, practices, and procedures of a particular field of specialization to the completion of difficult assignments.
    • Reviews progress and evaluates results.
    • Recommends changes in procedures and processes.
    • Assignments are broad in nature, requiring originality and ingenuity.
    • Has appreciable latitude for unreviewed action or decision.
    • Guide and direct design engineers and senior design engineers in the same project.
    • Fundamental understanding of IPC and IEC requirements as well as ISO organization related to electrical.
    • Perform formal risk analysis and develop software mitigation. SW build, change control, and development/test process improvement.
    • Development of research prototypes used to evaluate new product concepts.
    • A desire to deliver a quality and innovative product that improves lives.
    • Contribute to the definition and specification of future designs.
    • Own/Support all phases of the product development lifecycle including design, implementation, debug, verification, validation, and transfer to manufacturing.

    Educational Qualifications-Bachelor’s degree in Software Engineering, Electrical Engineering, or related field. M.S. in Software Engineering, Electrical Engineering preferred.

    Required Experience–

    • Requires a minimum of 5 years experience.
    • Familiar with concepts of design input, design output, trace-ability, and risk analysis.
    • Able to debug software and hardware/schematics at higher level using logic analyzers, oscilloscopes, and simulators.
    • Experience in concurrent cross-platform development preferred.
    • Demonstrates mastery in system level software (drivers, RTOS, and test applications) in embedded environment.
    • Expertise in debugging embedded systems without or with little emulator support.
    • Understands product development processes including: Change Control & Design Control. Software Development Life Cycle . Fluent in: C/C++, Object Oriented Coding, Windows Embedded Agile Testing Tools: Code Warrior, Perforce or similar, Doxygen, Lab View, Matlab, Microsoft Visual Stud. Knowledge in embedded system design required. Understand integration of software and hardware required.
    • Competent with Microsoft Office (Outlook, Excel, Word, etc.).
    • Must possess excellent oral and written communications.

    Email resume to info@vastekgroup.com or Apply to Fax # 858-810-0895

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