Test Specialist

Greetings from TATA Elxsi......!

Job Position - Test Specialist

Experience - 4+ years

Location - Pune

Job description -:

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 strong 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