V&V EngineerKatalyst HealthCares & Life Sciences • Hercules, CA
V&V Engineer
Katalyst HealthCares & Life Sciences • Hercules, CA
[job_card.variable_days_ago]
[job_preview.job_type]
- [job_card.full_time]
[job_card.job_description]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. 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.
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 :
Education & Experience :
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