Full-time
Medical Device Validation (TMV) Engineer
Posted by PB Consulting • danvers, massachusetts, United-States
About the Role
Roles & Responsibilities
- Develop and write clear and detailed TMV protocols, test procedures, validation plans, and final reports
- Define acceptance criteria and ensure alignment with regulatory and quality requirements
- Interpret engineering drawings, specifications, and test methods to design validation approaches
- Perform and analyze Gage R&R studies to assess measurement system capability
- Select appropriate measurement tools and ensure accuracy of inspection methods
- Collaborate closely with Engineering, Quality, Operations, and R&D teams to support validation activities
- Ensure all documentation is audit-ready and compliant with ISO standards and medical device regulatory requirements
- Support training of operators, engineers, and quality personnel on validated inspection m...
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