Test Method Validation Engineer

Job Summary:

Test Method Validation (TMV) Engineer

• Develop, execute, and document

  Test Method Validation (TMV)

  protocols and reports for medical device products.
• Perform method validation activities in accordance with

  FDA, ISO 13485, ISO 14971, and applicable regulatory requirements

  .
• Design and conduct studies for

  Accuracy, Precision, Repeatability, Reproducibility, Linearity, Robustness, and Measurement System Analysis (MSA/Gage R&R)

  .
• Collaborate with R&D, Quality, Regulatory Affairs, Manufacturing, and laboratories to establish validated test methods.
• Support product verification, design validation, process validation, and complaint investigations.
• Perform statistical data analysis and prepare technical reports.
• Ensure traceability and documentation within Design History File (DHF) and quality management systems.
• Participate in audits and regulatory inspections by providing TMV-related documentation.

• Strong knowledge of

  Test Method Validation (TMV)

  principles.
• Experience with

  Medical Device Verification & Validation (V&V)

  activities.
• Knowledge of

  ISO 13485, ISO 14971, Design Controls, DHF, GMP, FDA 21 CFR Part 820/QMSR

  .
• Experience in

  MSA, Gage R&R, Statistical Analysis, Minitab/JMP

  .
• Understanding of mechanical, electrical, biocompatibility, packaging, or analytical testing methods.
• Strong technical writing and documentation skills.