We anticipate the application window for this opening will close on - 5 Jan 2026

 

At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You’ll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world.

A Day in the Life

A career at Medtronic is like no other. We’re purposeful. We’re committed. And we’re driven by our Mission to alleviate pain, restore health and extend life for millions of people.  Help us engineer the extraordinary!

Help bring the next generation of life-changing medical technology to patients worldwide. We reward you in the ways that matter most to you. We offer a wide range of benefits and rewards programs to recognize the important role you play in our Mission to transform healthcare. Learn more about Medtronic benefits and compensation at the bottom of this job description.

We are currently looking for an Associate Risk Management Engineer to join Medtronic Neuromodulation and Pelvic Health to drive the development of safe and effective implantable medical systems and support sustaining activities.  

Location: This position will be a hybrid role with the expectation of being onsite in Fridley, Minnesota four days a week.

In this critical role as an Associate Risk Management Engineer, you will work closely with multidisciplinary project teams to develop products that are safe and effective for the patients and users by evaluating and driving improvements in the design, reliability, and safety. You will also engage in sustaining activities to support products and systems throughout the lifecycle.  This role is people oriented, requiring excellent collaboration and communication skills; it also requires persnickety attention to detail.

Responsibilities may include but are not limited to:

• Maintain a working knowledge of ISO 14971 and basic risk management practices such as Hazard Analysis and Failure Mode and Effects Analysis (FMEA).
• Assist in implementing risk management activities under guidance from senior engineers.
• Perform routine updates and maintenance of risk management documentation and tools.
• Ensure risk files remain current and compliant with applicable procedures.
• Collaborate with cross-functional teams (including Design, Human Factors, Medical Safety, Reliability and Post-Market Quality) to ensure that all hazards associated with medical devices are identified, the associated risks are estimated, evaluated, and that product/system performance is quantifiably predicted.
• Work with project teams to ensure that risk controls are identified and properly implemented, verified, and validated.
• Evaluate impact of potential issues to patient safety and product performance
• Perform and document Risk Reviews to communicate results of the risk management process to the cross-functional teams.
• Create and maintain compliant documentation to meet project deliverables and support audits.

Must Have: Minimum Requirements

• Requires a Baccalaureate degree in Engineering or technical discipline with 0 years of experience required

Nice to Have  

• Degree in Biomedical Engineering or a related technical field. 
• Exposure to or experience in a regulated industry, preferably medical devices. 
• Ability to work collaboratively within cross-functional teams and communicate effectively. 
• Proactive and detail-oriented, with a willingness to take initiative and follow through on assigned tasks. 
• Strong analytical and problem-solving skills, with the ability to learn and apply new concepts quickly. 
• Growth mindset, eager to develop technical skills and adapt in a dynamic environment. 
• Understanding of statistical methods and their application in engineering. 
• Familiarity with regulatory standards such as 21 CFR Part 820 and ISO 13485. 
• Awareness of Risk Management principles (ISO 14971) and introductory knowledge of techniques such as Design Failure Mode and Effects Analysis (DFMEA). 
• Exposure to or interest in working with Design, Quality, Regulatory, Clinical, and/or Manufacturing teams. 
• Interest in learning Design for Reliability (DfR), Design for Manufacturability, and other robust design practices.

Physical Job Requirements

The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position. 

The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an empl