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Verification & Validation Engineer

Verification & Validation Engineer

STAFTONIC LLCRaleigh, NC, United States
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Verification & Validation Engineer Role Overview : Support product verification, validation, and compliance testing for electromechanical medical devices from prototypes to final design. Develop and execute test methods, analyze results, and ensure compliance with 21 CFR 820 and ISO 13485. Key Responsibilities : Develop and execute verification / validation protocols (IQ / OQ / PQ) for components and systems. Perform functional testing of mechanical and electrical assemblies. Design test cases, setups, and fixtures; analyze test data and report results. Conduct pre-compliance EMC testing and troubleshoot failures. Ensure compliance with medical device standards and risk management. Collaborate with R&D, QA, manufacturing, and project teams. Create and maintain clear documentation and traceability in ALM. Requirements : Bachelor’s degree in Engineering with 3+ years in V&V for electromechanical systems. Hands-on experience with lab equipment (oscilloscope, DMM, gauges). Skilled in root cause analysis (FMEA, Fishbone, 5 Whys). Knowledge of electrical schematics, mechanical drawings, and medical device standards. Experience with LabVIEW and automated testing fixtures preferred.

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Validation Engineer • Raleigh, NC, United States