Medical Device Validation (TMV) Engineer

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 methods and best practices Contribute to continuous improvement of validation processes and quality systems Required Skills Experience in preparing TMV (Test Method Validation) protocols and reports, and executing validation activities Strong understanding and practical application of Gage R&R (Repeatability & Reproducibility) studies Ability to select and use appropriate measurement tools such as vernier calipers, micrometers, and other precision instruments Knowledge of validation principles within medical device or regulated manufacturing environments #J-18808-Ljbffr Veriipro