Test Method Validation Engineer

Job Summary

To support the development and validation of complex electromechanical medical devices, the contract Test Method Validation Engineer will develop and validate test methods, execute validation protocols, and ensure compliance with FDA and ISO 13485 regulations.

Key responsibilities

• Develop, qualify, and validate test methods for complex electromechanical medical devices
• Create and execute Test Method Validation (TMV) protocols and reports, including statistical analysis
• Support Design Verification (DV) and Design Validation (DVal) activities while maintaining full requirements traceability

Required qualifications

• Bachelor's degree in Mechanical Engineering, Biomedical Engineering, Electrical Engineering, or a related engineering discipline
• Experience developing and validating test methods for medical devices
• Strong knowledge of Test Method Validation (TMV), Measurement System Analysis (MSA), and Gauge R&R
• Experience supporting Design Verification (DV) and Design Validation (DVal)
• Knowledge of FDA regulations, ISO 13485, and medical device Design Controls