Job Summary:

We are seeking an experienced Test Method Validation (TMV) Engineer to support verification and validation activities for medical device products. The candidate will be responsible for developing, validating, and documenting test methods used to evaluate product safety, performance, reliability, and compliance with regulatory requirements.

Key Responsibilities:

- 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.

Required Skills:
- 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.
- Robust technical writing and documentation skills.

📌 Test Method Validation Engineer (Pune)
🏢 Tata Elxsi
📍 Pune