Risk Management Engineer II -Neuro

Medtronic-posted 1 day ago

$84,000 - $126,000/Yr

Full-time • Mid Level

Hybrid • Minneapolis, MN

5,001-10,000 employees

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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 a 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 a 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.

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.

Requires an Engineering Baccalaureate degree and minimum of 2 years of relevant experience OR a Master’s degree with a minimum of 0 years relevant experience.

Degree in biomedical engineering or a related technical field.
Background in a highly regulated industry, ideally with implantable medical devices.
Strong leadership and collaboration skills, with the confidence to voice informed opinions and the emotional intelligence to build consensus across teams.
Self-driven and proactive, with a demonstrated ability to take initiative, work independently, and follow through without the need for constant direction.
Critical thinker and problem solver, skilled at connecting information from diverse sources to generate insights and drive innovative solutions.
Growth-oriented mindset, eager to learn, experiment with new ideas, and adapt in a dynamic, fast-paced environment.
Experience applying statistical methods.
Familiarity with regulatory standards such as 21 CFR Part 820 (Quality System Regulation) and ISO 13485.
Knowledge of Risk Management principles (ISO 14971) and techniques such as Design Failure Mode and Effects Analysis.
Ability to independently lead investigations to identify system/product failures, hazards, hazardous situations, and harms.
Experience working with or alongside Design, Quality, Regulatory, Clinical and/or Manufacturing teams.
Understanding of Design for Reliability (DfR), Design for Reliability and Manufacturability (DRM), Design for Six Sigma (DFSS), Design for Lean Sigma (DFLS), and other robust design practices.

Medtronic offers a competitive Salary and flexible Benefits Package
A commitment to our employees lives at the core of our values.
We recognize their contributions.
They share in the success they help to create.
We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage.
Health, Dental and vision insurance, Health Savings Account, Healthcare Flexible Spending Account, Life insurance, Long-term disability leave, Dependent daycare spending account, Tuition assistance/reimbursement, and Simple Steps (global well-being program).
Incentive plans, 401(k) plan plus employer contribution and match, Short-term disability, Paid time off, Paid holidays, Employee Stock Purchase Plan, Employee Assistance Program, Non-qualified Retirement Plan Supplement (subject to IRS earning minimums), and Capital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums).

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