Careers That Change Lives 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 three days a week. A Day in the Life 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 thorough knowledge and understanding of ISO 14971 and risk management practices, such as Hazard Analysis and Failure Mode and Effects Analysis. 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. Ensure harmonization of risk management strategies across projects and their lifecycle by communicating with other Risk Management team members that share in varying pieces of the risk management lifecycle. Identify and act upon opportunities for continuous improvement of the Risk Management Process Provide input to design/process development, design controls, and design validation for achieving required levels of product safety and performance. Create documentation in compliance with applicable procedures to meet project deliverables. Must Have: Minimum Requirements Bachelor’s degree in Engineering or technical discipline 0 years of experience required. Nice to Have Experience in the application of statistics. Experience in a highly regulated industry, preferably implantable medical devices. Experience with 21 CFR Part 820 (Quality System Regulation), ISO 13485, etc. Experience in the application of Risk Management (ISO 14971) and hazard analysis and risk analysis techniques (e.g., PHA, HA, FTA, DFMEA). Ability to independently lead investigations to identify system/product failures, hazards, hazardous situations, and harms. Exposure to or experience working in or with Design, Quality, Regulatory, Clinical and/or Manufacturing Knowledge of Design for Reliability (DfR), Design for Reliability and Manufacturability (DRM), Design for Six Sigma (DFSS), Design for Lean Sigma (DFLS), and/or robust design practices.