Senior Product Verification Engineer - Medical Device

Title : Senior Product Verification Engineer
Location: Pennsylvania, PA
Duration: 6+ Months

Key Responsibilities
Develop and execute Design Verification (DV) plans, protocols, and reports
Perform Test Method Validation (TMV) to ensure test methods are accurate, repeatable, and reproducible
Develop test methods, acceptance criteria, sampling plans, and verification strategies
Conduct verification testing for single-use sterile medical devices
Analyze test data and investigate failures, deviations, and root causes
Maintain traceability between design requirements, risk analysis, and verification testing
Prepare technical documentation for DHF and regulatory submissions
Collaborate with R&D, Quality, Regulatory, and Manufacturing teams
Ensure compliance with FDA, ISO 13485, ISO 14971, and applicable standards

Requirements
Bachelor's degree in Engineering, Biomedical Engineering, or related field
Strong hands-on experience with Design Verification (DV)
Proven experience with Test Method Validation (TMV)
Direct experience with single-use sterile medical devices
Strong knowledge of medical device Design Controls and Risk Management
Experience preparing verification protocols, reports, and technical documentation
Strong data analysis, troubleshooting, technical writing, and communication skills