At Medtronic you can begin a life-long career of exploration and innovation while helping champion healthcare access and equity for all. Youll 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. Were purposeful. Were committed. And were 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 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.

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

• Requires an Engineering Baccalaureate degree and minimum of 2 years of relevant experience OR a Masters degree with a minimum of 0 years relevant experience.

Nice to Have

• 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.

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 employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. For Office Roles: While performing the duties of this job the employee is regularly required to be independently mobile. The employee is also required to interact with a computer and communicate with peers and co-workers. Contact your manager or local HR to understand the Work Conditions and Physical requirements that may be specific to each role.

Benefits & Compensation

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.

The following benefits and additional compensation are available to those regular employees who work 20 hours per week: Health Dental and vision insuranceHealth Savings AccountHealthcare Flexible Spending AccountLife insurance Long-term disability leaveDependent daycare spending accountTuition assistance/reimbursement andSimple Steps (global well-being program).

The following benefits and additional compensation are available to all regular employees:Incentive plans 401(k) plan plus employer contribution and matchShort-term disabilityPaid time offPaid holidaysEmployee Stock Purchase PlanEmployee Assistance ProgramNon-qualified Retirement Plan Supplement (subject to IRS earning minimums) andCapital Accumulation Plan (available to Vice Presidents and above or subject to IRS earning minimums).

Regular employees are those who are not temporary such as interns. Temporary employees are eligible for paid sick time as required under applicable state law and the Employee Stock Purchase Plan. Please note some of the above benefits may not apply to workers in Puerto Rico.

Further details are available at the link below:

Medtronic benefits and compensation plans

About Medtronic

We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions.
Our Mission to alleviate pain restore health and extend life unites a global team of 95000 passionate people.
We are engineers at heart putting ambitious ideas to work to generate real solutions for real people. From the R&D lab to the factory floor to the conference room every one of us experiments creates builds improves and solves. We have the talent diverse perspectives and guts to engineer the extraordinary.

Learn more about our business mission and our commitment to diversity here.

It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age color national origin citizenship status physical or mental disability race religion creed gender sex sexual orientation gender identity and/or expression genetic information marital status status with regard to public assistance veteran status or any other characteristic protected by federal state or local addition Medtronic will provide reasonable accommodations for qualified individuals with disabilities.