Design Quality Engineer II

We anticipate the application window for this opening will close on - 28 Aug 2026   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                     Position Description The Design Quality Engineer II, supporting Released Product Engineering (RPE) within the Acute Care & Monitoring (ACM) Operating Unit, contributes to product quality, reliability, and regulatory compliance through quality engineering support for sustaining engineering and product change activities. This role partners with R&D, Regulatory Affairs, Manufacturing, Operations, and Program teams to help ensure design changes and released product engineering activities are executed in accordance with Medtronic’s Quality Management System (QMS), applicable standards, and global regulatory requirements. The Design Quality Engineer II applies Design Controls, Risk Management, and Change Control processes to support evaluation, implementation, and release of product improvements across the ACM product portfolio. If you are passionate about solving technical problems, improving product quality, and collaborating across functions to support safe and reliable medical devices, this role offers an opportunity to make meaningful impact while continuing to grow your design quality engineering expertise.

Review new and modified product designs to help assess impact to product requirements, patient safety, reliability, standards compliance, and regulatory requirements. Support design change activities in accordance with Medtronic’s QMS and applicable global regulations and standards, including ISO 13485, EU MDR, and FDA Quality System Regulation / QMSR expectations. Support the development and maintenance of risk management documentation, including Risk Management Plans, hazard analyses, DFMEAs, risk assessments, and Risk Management Reports in accordance with ISO 14971. Review and provide input to verification and validation strategies, test plans, protocols, reports, and supporting documentation to help ensure alignment with product requirements and applicable standards. Provide quality engineering support for sustaining engineering initiatives across technical disciplines such as electrical, software, mechanical, optical, algorithms, human factors, and data analysis. Collaborate with cross-functional partners including R&D, Operations, Regulatory Affairs, Marketing, Manufacturing, and Program Management to support timely and compliant execution of product changes. Support investigations, issue evaluation, CAPA activities, root cause analysis, and failure analysis as needed for released product quality concerns. Apply quality engineering tools and problem-solving methods to help identify risks, evaluate data, and support product and process improvements. Contribute to continuous improvement initiatives that enhance product quality, reliability, manufacturability, and compliance. Communicate technical and quality information clearly through documentation, review comments, meetings, and cross-functional collaboration.

Bachelor’s degree in Engineering, Science, or a related technical discipline and a minimum of 2 years of relevant Engineering, Quality, or regulated industry experience; or an advanced degree with relevant academic, project, internship, or industry experience. Specialized Skills or Experience Required / Strongly Preferred for Success Experience in the medical device industry or another regulated industry with similar quality and regulatory requirements. Working