Role Brief:

Lead end-to-end Verification & Validation (V&V;) for medical device new product development, ensuring regulatory compliance and high product quality.

Roles and Responsibilities:

Lead test strategy, planning, and execution for NPD programs

Define V&V; approach aligned with IEC 62304, ISO 13485, FDA

Manage functional, system, integration, and regression testing

Collaborate with R&D;, system engineering, product teams

Drive risk-based testing for safety-critical systems

Track quality metrics, defects, and test progress

Support audits, design reviews, and regulatory submissions

Must-Have Skills

Experience in medical device / regulated domain testing

Proficiency in JIRA / ALM tools

Strong understanding of SDLC / V-Model





Proven test leadership and team management

Knowledge of IEC 62304, ISO 13485, FDA compliance

Good-to-Have Skills

Experience in Agile / Scrum

Exposure to embedded systems & HMI testing

Knowledge of CI/CD pipelines & automation integration

Familiarity with ISO 14971 risk management

Education

Bachelor’s in computer science / Electronics / Biomedical / equivalent

Experience

10 to 15 years in System testing/V&V;

3 to 5+ years in Test Leadership roles

Experience in recent product development programs

📌 Verification and Validation Manager /Architect (Medical Devices) (Pune)
🏢 Tata Elxsi
📍 Pune