Associate Risk Management Engineer - Neuro

Associate Risk Management Engineer

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 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 offer a wide range of benefits and rewards programs to recognize the important role you play in our Mission to transform healthcare.

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. 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.

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.

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.

Salary ranges for U.S (excl. PR) locations (USD):$68,800.00 - $103,200.00 This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP). The base salary range is applicable across the United States, excluding Puerto Rico and specific locations in California. The offered rate complies with federal and local regulations and may vary based on factors such as experience, certification/education, market conditions, and location. Compensation and benefits information pertains solely to candidates hired within the United States (local market compensation and benefits will apply for others). The following benefits and additional compensation are available to those regular employees who work 20+ hours per week: 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). The following benefits and additional compensation are available to all regular employees: 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).

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.

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 95,000+ 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.

We change lives. Each team member, each day, helps to improve and redefine how the world treats the most pressing health conditions, from heart disease to diabetes. Our industry leadership comes from the passion and ingenuity of our people. That's who we are. Working alongside one another, we use science, medicine, and a profound understanding of the human body to build extraordinary technologies that can transform lives.

We build extraordinary solutions as one team. With one Medtronic Mindset defining how we work. Speed and decisiveness run through our DNA. Diverse perspectives inspire our bold answers to any challenge that comes our way. And we deliver results the right way, breakthrough after patient breakthrough.

This life-changing career is yours to engineer. By bringing your ambitious ideas, unique perspective and contributions, you will…

• Build a better future, amplifying your impact on the causes that matter to you and the world
• Grow a career reflective of your passion and abilities
• Connect to a dynamic and inclusive culture that welcomes the challenge of life-long learning

These commitments set our team apart from the rest:

• Experiences that put people first. Respect for people is the hallmark of our humanity. It fuels our team to positively impact even a single life. And it means we put our people first at Medtronic as well, creating a culture of belonging and always pushing to get you the career-building resources you need.
• Life-transforming technologies. No matter your role, you contribute to technologies that transform lives. What we build empowers patients to live life on their terms.
• Better outcomes for our world. Here, it's about more than the bottom line. Our Mission to improve human welfare drives us. We advance healthcare, society, and equity with every design, inside and outside our walls.
• Insight-driven care. Fresh viewpoints. Cutting-edge AI, data, and automation. You're shaping the future of healthcare technology and defining the next generation of breakthroughs in care.

It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age,