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V&V Engineer
V&V EngineerKatalyst HealthCares & Life Sciences • Hercules, CA
V&V Engineer

V&V Engineer

Katalyst HealthCares & Life Sciences • Hercules, CA
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  • [job_card.full_time]
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Job Summary :

  • The System Verification & Validation (V&V) Engineer is responsible for executing system-level verification and validation activities to ensure requirements traceability, regulatory compliance, and generation of objective evidence for design releases and sustaining changes in regulated medical device environments.

Roles & Responsibilities :

  • Execute system-level Verification & Validation (V&V) activities.
  • Develop and execute V&V Plans, Protocols, and Reports.
  • Maintain requirements traceability and Design History File (DHF) documentation.
  • Perform hardware, software, and laboratory testing.
  • Ensure compliance with ISO standards.
  • Communicate project status and present objective evidence during design and review meetings.
  • Implement and support test automation for regression and system-level testing.
  • Education & Experience :

  • Bachelor's or Master's degree in Engineering (Electrical, Biomedical, Mechanical, or Software).
  • – years of experience in system-level V&V for IVD / medical devices or complex electromechanical systems.
  • Hands-on experience in protocol design and execution in regulated environments.
  • Experience in test automation.
  • Preferred experience with wet lab workflows, including sample handling and reagents.
  • Familiarity with ISO , ISO , and IEC standards.
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