We are seeking a Validation & Verification Engineer with 10+ years of experience in the medical device industry . The ideal candidate will have robust expertise in Design Verification & Validation (V&V;) , Human Factors Engineering , FDA 21 CFR Part 820 , traceability, regulatory compliance, and V&V; documentation.
Key Skills:
- Design Verification & Validation (V&V;)
- Human Factors & Usability Engineering
- FDA 21 CFR Part 820
- Traceability (User Needs, Design Inputs, Verification & Validation)
- V&V; Protocols, Test Plans & Reports
- Medical Device Regulatory Compliance
- Cross-functional collaboration
- ISO 13485, ISO 10993, EU MDR (preferred)
- In Vitro/In Vivo Testing (preferred)