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. 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

Required Skills & Qualifications
Technical Skills
• Strong experience in manual testing of embedded/software systems
• Experience in API testing, interface testing, and system-level testing
• Knowledge of Linux/embedded systems is preferred
• Familiarity with version control tools (Git, SVN)

Soft Skills
• Strong analytical and problem-solving abilities
• Excellent communication and documentation skills
• Ability to work in a fast-paced, multi-team environment
• Proactive mindset with ownership attitude

Preferred Domain Experience
• Medical Device Software
• Healthcare Platforms
• Regulated Product Develo

📌 Python Automation testing (India)
🏢 Tata Elxsi
📍 India