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 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

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 quick-paced, multi-team environment
- Proactive mindset with ownership attitude

Preferred Domain Experience

- Medical Device Software
- Healthcare Platforms
- Regulated Product Development Lifecycle
- IEC 62304-compliant SDLC processes

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