V&V Manager / Architect / Lead

Tata Elxsi is known for its ability to create consumer delight, build loyalty, and drive revenue growth in the field of MedTech ER&D. From wearables for the health-savvies to critical medical devices and drugs that save thousands of lives daily, we at Tata Elxsi help global healthcare brands design, engineer, and commercialize differentiated and sustainable products for the competitive marketplace. Join our team of award-winning designers, technologists, and digital experts and craft your future. We are looking for the right candidate who will be fit for the position of V & V Manager.

Qualification:

• 10-15 years of relevant experience with a minimum of 4 years in medical device or other regulated industry
• Experience in NPD programs in the role of V&V engineer/lead and Good experience in Manual & Automation testing

Job Responsibilities:

• Well aware of V&V life-cycle including different methodologies especially V model & Agile (Scrum)
• Participate in design reviews and ensure design requirements and specifications are testable
• Creates test strategies that increase test coverage, validate scalability and improve quality
• Prepares a master test plan for testing schedule and tracks actual progress against schedule; manages resources to meet schedule and resolve respective impediments that come on the way
• Create metrics based on project data that can help higher management in decision-making
• Create metrics based on project data that can help higher management in decision-making
• Maintains awareness of current regulatory trends and their impact on the verification and validation status of equipment and processes
• Supports the qualification of verification lab, and productivity improvement efforts, including testing, building fixtures, calibration, and data collection

Required Skills:

• Solid experience in functional and performance testing and driving system specs into test plans
• Good knowledge & experience in JIRA, SVN, DOORs,
• Knowledge of ISO 13485, ISO 14971, IEC 60601-1, 2, 6, 8 safety standards, IEC 62304 & IEC 61010, etc
• Strong understanding of safety risk management, including FMEA, design mitigations, and risk management standards
• Good communication, presentation, team management, and stakeholder management skills
• Be a role model for the Test team and be approachable and Agility to gear up upscaling and upskilling constantly

Desired Skill:

• ISTQB Certification
• Designs and implements automated tests using tools validated within the QA team and Understanding of firmware, hardware, and various compliance standards which will help to effectively validate the respective system testing