Test Specialist

Job description

Greetings From TATA Elxsi..........! **Job Title: Medical Device Verification Engineer (Manual + Automation)** **Location: Pune** **Experience: 5 + years** **Domain: Medical Device / Healthcare Software** **Job Summary** We are looking for a highly skilled **Medical Device Verification Engineer** with strong expertise in **manual verification and test automation using Python and Robot Framework**. 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