Medical Device Verification Engineer (Manual + Automation)
Location: Pune
Experience: 4 + years
Domain: Medical Device / Healthcare Software preffered
Job Summary
We are looking for a highly skilled Medical Device Verification Engineer with strong expertise in manual verification and test automation. The candidate will be responsible for end-to-end verification and validation (V&V;) activities in compliance with regulatory standards such as IEC 62304, ISO 14971.
The role requires solid analytical skills, hands-on automation experience, and a deep understanding of medical device software lifecycle processes.
Key Responsibilities
Verification & Validation
- Perform manual verification and validation of medical device software, firmware,
and system-level requirements
- Develop and execute test cases, test protocols, and traceability matrices aligned with system requirements
- Ensure compliance with IEC 62304, ISO 13485, ISO 14971, and FDA regulatory requirements
- Participate in requirement reviews, design reviews,
- Perform system integration testing, regression testing, and defect validation
Test Automation
- Design and develop automation frameworks using Python and Robot Framework
- Automate functional, regression, and system-level test cases
- Develop reusable libraries and optimize automation coverage
- Analyze test results and generate automation reports
📌 Test Specialist (Pune)
🏢 Tata Elxsi
📍 Pune
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