Boston Scientific IC - Technical Sales Ningbo 

China, Zhejiang, Ningbo 

566996391

India-Maharashtra, Pune

Purpose Statement:

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.