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 robust 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 workplace
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 (India)
🏢 Tata Elxsi
📍 India