Job Title —Validation Engineer (Job Code 002)

Company —Vastek Inc.

Location —San Diego, California.

Job Description:(VAStek Inc. has openings in San Diego, CA) Validation Engineer (Job Code 002): Support and review equipment, process, and facility qualification and validation activities. Create and update master design verification and design validation documents for existing products. Execute test protocols and test method protocols. Analyze test scripts. Perform qualification and design verification testing. Identify defects in product design, verification, validation, manufacturing, and testing activities. Perform root cause analysis. Write and execute risk assessment and procedures and perform risk management activities. Conduct quality assurance tests and improve the quality of products. Will work in various unanticipated locations throughout the U.S.

Requires Master’s in Computer Science, Engineering, or related.$93,184.00 per year.

Send resume to and refer to job title to swapna@vastekgroup.com .


Job Title —Quality Assurance Analyst

Company —Vastek Inc.

Location —San Diego, California.

Job Description:(VAStek Inc. has openings in San Diego, CA) Quality Assurance Analyst: Develop validation and testing strategies for systems/applications that are within the scope of validation affiliated with FDA regulations. Review the validation framework and validation plans before the testing of the system. Review and validate quality deliverable and system documentation against federal requirements. Approve quality deliverable and validation report. Ensure that validated systems are in accordance with regulatory requirements and quality objectives. Identify and review potential hazards and risks in systems/applications that are subjected to validation. Ensure that risk analysis, risk mitigation strategies, and modes of control are performed and documented. Ensure that defects generated from the testing process are reviewed and resolved prior to system production. Verify that all components of the system are tested together and ensure the system performs functionally and operationally. Confirm validation evidence is complete and documented. Verify that the system operates according to requirements and design specifications. Will work in various unanticipated locations throughout the U.S.

Requires Bachelor’s in Engineering or related. $78,208.00 per year.

Send resume to and refer to job title to swapna@vastekgroup.com .


Job Title —Director of Engineering

Company —Vastek Inc.

Location —San Diego, California.

Job Description:(VAStek Inc. has an opening in San Diego, CA) Director of Engineering: Collaborate with the CEO in setting and driving organizational vision, operational strategy, and hiring needs. Brainstorm and create new project strategies. Identify sales and services that would appeal to new clients. Review timeframes and budgets. Create sales pitches. Execute sales objectives. Plan and oversee new marketing initiatives. Manage client accounts. Oversee company operations and employee productivity. Participate in pricing the solution/service. Attend industry functions and provide information on market and creative trends. Present business trends to senior level management to develop new services, products, and distribution channels. Identify opportunities for campaigns, services, and distribution channels that will lead to an increase in sales. Develop and implement a recruiting plan to source top talent in the technology industry. Up to 30% domestic and international travel required.

Requires Master’s in Project Management, Engineering Management, or related. $141,794.00 per year.

Send resume to and refer to job title to swapna@vastekgroup.com .


Job Title —Industrial Engineer

Company —Vastek Inc.

Location —San Diego, California.

Job Description:(VAStek Inc has openings in San Diego, CA) Industrial Engineer: Work with customers and outside vendors in the design and development of all program packaging requirements, in tooling, equipment, component and material development, and in product, project or system development issues. Recommend methods to improve utilization of personnel, material, and utilities. Collect and analyze data to determine standards and establish quality and reliable objectives of the finished product. Coordinate tasks and requirements with interfacing departments and locations to maximize product reliability and minimize costs. Will work in various unanticipated client locations throughout the U.S.

Requires a Bachelors in Engineering or related and 1 year of experience. $78,208.00 per year.

Send resume to and refer to job title to swapna@vastekgroup.com .


Job Title —Manufacturing Engineer

Company —Vastek Inc.

Location —San Diego, California.

Job Description:(VAStek, Inc. has openings in San Diego, CA) Manufacturing Engineer: Test and develop manufacturing process methods. Author and execute process Validation Protocols (IQs, OQs, PQs). Review Corrective Action and Preventive Action (CAPA). Conduct review of manufacturing, quality control, and packaging specifications as part of complaint investigation to ensure products were manufactured according to specifications. Prepare TMV (Test Method Validation) and deviation reports and Gage R&R analysis reports. Provide technical support to fabrication processes, troubleshoot existing assembly methods and design new cost effective and efficient production assembly plans. Will work in various unanticipated locations throughout the U.S.

Requires Masters in Engineering or related. $93,184.00 per year.

Send resume to and refer to job title to swapna@vastekgroup.com .


Job Title —Product Development Engineer

Company —Vastek Inc.

Location —San Diego, California.

Job Description:(VAStek, Inc. has openings in San Diego, CA) Product Development Engineer: Plan, engineer, develop, modify, implement, and support medical devices through the application of design control, change control, and engineering practices. Develop, modify, and implement Class II Medical Devices (catheters, blood pressure cuffs, pregnancy test kits, syringes, blood transfusion kits, contact lenses, surgical gloves, and absorbable sutures) and Class III Medical Devices (breast implants, pacemakers, defibrillators, high-frequency ventilators, cochlear implants, fetal blood sampling monitors, and implanted prosthetics). Develop new concepts from initial design to market release. Write proposals for existing clients to achieve new deliverables within an existing phase or as a part of ongoing efforts. Execute protocols and reports as needed to support validation activities, including Design Verification. Conduct feasibility studies of designs to determine ability to function as intended. Maintain detailed documentation throughout all phases of product development. Conduct risk analysis for products under development. Participate in client meetings and communicate with the team to ensure a two-way exchange of information. Execute product development deliverables from concept through commercialization. Will work in various unanticipated locations throughout the U.S.

Requires Masters in Engineering or related. $111,675.00 per year.

Send resume to and refer to job title to swapna@vastekgroup.com .


Job Title —Research Development Chemist

Company —Vastek Inc.

Location —San Diego, California.

Job Description:(VAStek, Inc. has openings in San Diego, CA) Research Development Chemist: Apply fundamental chemistry principles to develop and validate new, safe, and effective products (metals, allergens by ELISA, toxins, carbohydrates, preservatives, and OTC drugs) treating the unmet needs of patients. Support R&D initiatives for new therapies and changes to the commercial product while adhering to policies. Perform sample preparations, testing, and analytical research on metals, allergens by ELISA, toxins, carbohydrates, preservatives, and OTC drugs using analytical equipment. Guide and perform analytical test method development and validation. Guide and perform studies on process characterization, optimization, and validation. Design, develop, and provide technical expertise in the research and development (R&D) of medical devices from conception to market release. Provide support to new product development and sustaining engineering teams and perform testing and analysis on medical devices for improvement and cost reduction. Collaborate with the R&D team and with Manufacturing and Quality functions to achieve business deliverables. Comply with applicable GMP, GLP, and ISO standards. Comply with applicable FDA and international regulatory laws and standards. Will work in various unanticipated locations throughout the U.S.

Requires Bachelor’s in Chemistry, Chemical Engineering, or related. $56,888.00 per year..

Send resume to and refer to job title to swapna@vastekgroup.com.


Job Title —Quality Engineer(Job Code 001)

Company —Vastek Inc.

Location —San Diego, California.

Job Description:(VAStek, Inc. has openings in San Diego, CA) Quality Engineer (Job Code 001): Support the validation team in writing qualification protocols and reports. Perform root cause investigations and CAPA process using quality tools. Develop and execute design of experiments and pre-validation activities. Assist in the development, implementation, and strict adherence to quality management systems. Develop and maintain quality control plans. Assist in the development and maintenance of PFMEAs. Provide CAPA responses to customer issues and audit findings. Perform Gage R&R and MSA and write test/inspection methods and procedures. Review design changes working closely with R&D in the transfer of safe and effective medical devices. Perform quality related activities and provide technical quality engineering support for design qualifications, design transfer, activities for regulatory submissions, product/process development, implementation of design control documents, and approval of product/process change. Will work in various unanticipated locations throughout the U.S.

Requires Master’s in Engineering or related. $93,184.00 per year.

Send resume to and refer to job title to swapna@vastekgroup.com.

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