Verification and Validation Manager /Architect (Medical Devices)

Job description

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 new product development programs