Additional Locations: India-Maharashtra, Pune Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance At Boston Scientific, we’ll give you the opportunity to harness all that’s within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges. With access to the latest tools, information and training, we’ll help you in advancing your skills and career. Here, you’ll be supported in progressing – whatever your ambitions. Responsible for leading the definition, design, and execution of system-level verification and validation strategies for complex medical device systems. This role ensures that systems meet intended use, regulatory requirements, and quality standards through rigorous testing and analysis. Key Responsibilities: Define and implement system-level V&V strategies, including test plans, protocols, and traceability to requirements. Lead the development and execution of test cases for hardware/software integrated systems. Analyze system behavior and performance, identify root causes of failures, and recommend corrective actions using tools like FMEA, 5 Whys, and fishbone diagrams. Collaborate with cross-functional teams to ensure test coverage aligns with system architecture and risk assessments. Develop and maintain dashboards and reporting tools to track test coverage and defect trends. Ensure compliance with regulatory standards (e.g., FDA, ISO 13485) and internal quality systems. Drive continuous improvement of V&V processes and tools to enhance efficiency, traceability, and test automation. Participate in design reviews and provide input on testability, reliability, and system integration risks. Solves system problems by analyzing the situation and recommending corrective or alternative actions. Detailed oriented engineer who owns the quality of the project. Develop robust, scalable systems for managing NCEP and CAPA process. Directs support personnel and project activities. Lead engineers in Systems V&V activities/methodologies and medical domain knowledge. Desired Experience and Skills: Bachelor’s or Master’s degree in Engineering (BE, BTech, ME, MTech) or equivalent. 13+ years of experience in systems-level V&V and product testing, good understanding of automation. Experience in regulated product development, preferably in the medical device industry. Proficiency in test management tools, defect tracking systems, and data analysis platforms. Demonstrated ability to lead cross-functional projects and mentor technical teams. Deep knowledge of systems engineering and V&V principles. Strong analytical and problem-solving skills. Effective communication and leadership in cross-functional settings. Highly accountable and responsible Commitment to quality, safety, and continuous improvement. Requisition ID: 609679 As a leader in medical science for more than 40 years, we are committed to solving the challenges that matter most – united by a deep caring for human life. Our mission to advance science for life is about transforming lives through innovative medical solutions that improve patient lives, create value for our customers, and support our employees and the communities in which we operate. Now more than ever, we have a responsibility to apply those values to everything we do – as a global business and as a global corporate citizen. So, choosing a career with Boston Scientific (NYSE: BSX) isn’t just business, it’s personal. And if you’re a natural problem-solver with the imagination, determination, and spirit to make a meaningful difference to people worldwide, we encourage you to apply and look forward to connecting with you!