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