V&V Manager /Architect (Medical devices)

Tata Elxsi is among the world's leading providers of design and technology services across industries, including automotive, broadcast, communications, healthcare, and transportation. Tata Elxsi works with leading OEMs and suppliers in the automotive and transportation industries for R&D, design, and product engineering services from architecture to launch and beyond.

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
• Drive automation strategy using C++, Squish, and frameworks
• Lead GUI testing for Qt/QML-based applications
• Ensure traceability via JIRA
• 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
• Strong hands-on in C++ testing & debugging
• Expertise in Qt/QML application testing (GUI validation)
• Experience with Squish for GUI automation
• Proficiency in JIRA / ALM tools
• Strong understanding of SDLC / V-Model
• Proven test leadership and team manageme nt
• 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
• 10–15+ years in software testing/V&V
• 3–5+ years in Test Leadership roles
• Experience in new product development programs