Verification and Validation Manager /Architect (Medical Devices)

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