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Chula Vista

    System Validation Engineer - Chula Vista, United States - Katalyst Healthcares and Life Sciences

    Katalyst Healthcares and Life Sciences
    Katalyst Healthcares and Life Sciences Chula Vista, United States

    5 days ago

    Default job background
    Description
    Responsibilities :
    • Interact with cross-functional project teams to provide inputs to project plans and schedules.
    • Develop V&V test plans, test procedures, requirements trace matrices, and test reports.
    • Assign project tasks and responsibilities to V&V team.
    • Quickly learn to use automated test tools and specialty test equipment; develop and validate Client test methods (TMV, DOE, Gage R&R studies).
    • Log defects and issues found during V&V activities and track to closure.
    • Plan and facilitate V&V formal technical review and design review meetings.
    Requirements:
    • Bachelor's degree in an engineering discipline; electrical engineering or mechanical engineer background preferred.
    • 5 years professional experience in the medical device industry.
    • Working knowledge of global medical device regulations, requirements, and standards.
    • Experience developing V&V test plans, test procedures, requirements trace matrices, and test reports.
    • Experience validating test methods (TMV) using methods such as DOE and Gage R&R
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