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

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