Senior Quality Engineer

Medtronic — Nanakramguda, Hyderabad, India

Careers that change lives start here. Medtronic is a global leader in healthcare technology with a Mission to alleviate pain, restore health, and extend life. Our 95,000 employees work across more than 150 countries to put patients first — developing innovative medical technologies that improve the lives of 72+ million patients each year. Your unique talents will help shape the future of healthcare while building a career grounded in purpose, growth, and impact. A Day in the Life As a Senior Quality Engineer you will be a key member of the Medtronic Quality Engineering team responsible for maintaining highest standards of product reliability and patient well-being through precise risk assessment and management. • Collaborating with cross-functional teams to develop comprehensive product risk management files, including the risk management plan, Hazard Analysis, PFMEA, Control plans/reports, Master validation plan/report, DFMEA, and risk management report, adhering to ISO 14971 standards. • Serving as a mentor to junior engineers, providing guidance and support in quality engineering practices within the realm of medical devices. Responsibilities may include the following and other duties may be assigned. Capability to conduct thorough reviews of new and modified product design documentation, assessing quality characteristics such as manufacturability, serviceability, testability, reliability, and compliance with product requirements. Subject matter expert in risk management for designated medical device products or platforms. Ensuring compliance with FDA Quality System Regulations, EU MDR, ISO 13485, ISO 14971, IEC 60601, and other relevant industry standards during product development and changes. Reviewing Design History Files and Technical Files to ensure alignment with applicable requirements. Delivering presentations on project status and issues to the QA organization and providing training to other departments on relevant procedures and policies. Participa

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