We anticipate the application window for this opening will close on - 12 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

At Medtronic, we bring bold ideas forward with speed and decisiveness to put patients first in everything we do. In-person exchanges are invaluable to our work. We’re working a minimum of 4 days a week onsite as part of our commitment to fostering a culture of professional growth and cross-functional collaboration as we work together to engineer the extraordinary.

         

         

Medtronic, a global leader in medical technology, services, and solutions, is seeking a 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 interest 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. 

Key Responsibilities: 

• 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  

Other potential responsibilities:

• 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. 

Minimum Requirements: 

• Bachelors degree in engineering or a related technical field

Preferred Qualifications: 

• Experience in medical devices, pharmaceuticals, or combination products

• Familiarity with medical devi