Prin Quality Engineer

Onsite

Lafayette, Colorado, United States of America

North Haven, Connecticut, United States of America

Boston, Massachusetts, United States of America

Minneapolis, Minnesota, United States of America

Full time

R72635

We anticipate the application window for this opening will close on - 11 Sep 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.

Medtronic, a global leader in medical technology, services, and solutions, is seeking a highly skilled and experienced Principal Risk Management Quality Engineer to join our innovative team. This role will be in the surgical operating unit within the new product development quality team. The ideal candidate will have a strong background in risk management, product development, design controls and regulatory compliance within the medical device industry.

This position requires a strong team player who is a self-starter, inquisitive, and a fast learner. This position plays a critical role in the development of medical devices, ensuring patient safety is embedded throughout the product lifecycle.

Develop and maintain comprehensive strategies for risk management activities, including:

• Collaborating cross-functionally to ensure the utmost product quality for patient safety
• Creating and maintaining the risk management file, including the risk management plans and reports, as well as conducting regular risk reviews.
• Leading hazard and risk analysis activities to identify potential risks and implement effective risk control measures.
• Leading Design Failure Modes and Effects Analyses (DFMEAs) in collaboration with project teams to systematically evaluate potential failure modes and their impacts.
• Analyzing and reviewing product complaints to anticipate and prevent future issues.
• Integrating product security measures to protect against potential vulnerabilities into the risk management file.
• Participating in Process FMEA/User FMEA development and integrating the Process FMEA/User FMEA into the risk management file.
• Leading design review and maintaining the risk management file throughout the product lifecycle
• Developing and managing post-market surveillance plans to monitor product performance and safety in the field.
• Leading field issue evaluation (including root cause analysis, risk evaluation, product containment strategy) during initial launch.
• Ensuring traceability between risk management file, requirements and design outputs utilizing a requirements management tool
• Evaluate the safety risk implications of design changes

• Lead and mentor teams in the development, implementation, and maintenance of the quality system processes and standards.
• Collaborate with cross-functional teams, to define and implement engineering and statistical processes that ensure product quality and compliance throughout the product lifecycle.
• Ensure compliance with relevant regulatory requirements, including FDA, ISO (e.g., 14971, 13485, 62304, FDA Part 820), and other international standards, and participate in regulatory audits and inspections.
• Oversee design validation and design verification activities of user needs and design inputs, including the development of test plans, protocols, test methods and reports.
• Ensure thorough and accurate documentation including test results, risk assessments, and reports.

• Education: Minimum bachelor’s degree in engineering, or a related technical field. Advanced degree is preferred
• Regulatory Knowledge: In-depth knowledge of FDA regulations, ISO 13485, ISO 14971, and other relevant standards.
• Problem-Solving: Strong analytical and problem-solving skills with the ability to conduct thorough root cause analysis.
• Communication: Excellent written and verbal…