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We anticipate the application window for this opening will close on - 5 Jun 2025

Position Description:

Sr. Risk Management Specialist for Medtronic, Inc located in Fridley, MN. Responsible for ensuring the safety of finished medical devices throughout the product lifecycle. Engage a cross-functional group to identify, evaluate, control, and prevent failures that can result in hazards when people use medical devices. Evaluates the product and system design to identify risk control mitigations to reduce failure occurrence. Utilize computer and software packages to include MS Office Suite, MS Project, and Minitab. Perform Risk Mgmt. Deliverables to include Use, Design and Process Failure Mode Effects Analysis (FMEA) and Product Hazard Analysis. Support design control deliverables to include Product Performance Specifications, Design Verification, Design Validation, Design Transfer, and Usability and Human Factor Engineering; approve product drawings/prints; provide support for Variable and Attribute Test Method Development and Validation. Provide support for Complaint and Product Failure Investigations, pre and post market root cause analysis, Corrective and Preventive Actions (CAPA) and Product Non-Conformances. Navigate government and quality regulations to include FDA 21 CFR part 820 requirements and ISO 13485, ISO 14971, European Union (EU) Medical Device Regulation (MDR), and State of the Art (SOTA). Apply probability concepts towards occurrence rate calculations in Product Hazard Analysis. *Multiple positions available. **Eligible for telecommuting from home within reasonable commuting distance from Fridley, MN. Will require physical presence at worksite in Fridley, MN at least several days a week. ***Employer will accept any suitable combination of education, training or experience. Relocation assistance is not available for this position. #LI-DNI

Basic Qualifications:

Master's degree in Mechanical, Industrial or related Engineering field, or Industrial Studies. Requires three (3) years of experience as a Reliability or Quality Engineer. Experience must include three (3) years of post-Bachelor's progressive experience in all of the following: Risk Mgmt. Deliverables including Use, Design and Process FMEA, and Product Hazard Analysis; Design Control Deliverables to include Product Performance Specifications, Design Verification, Design Validation, and Design Transfer, and Usability and Human Factor Engineering; Complaint and Product Failure Investigations, pre and post market root cause analysis, CAPA, and Product Non- Conformances; FDA 21 CFR 820, ISO 13485, and ISO 14971 European Union (EU) Medical Device Regulation (MDR), and State of the Art (SOTA); Application of statistics for risk estimation.

Alternate Qualifications:

Bachelor's degree in Mechanical, Industrial or related Engineering field, or Industrial Studies. Requires five (5) years of post-Bachelor's progressive experience as a Reliability or Quality Engineer. Experience must include five (5) years of post-Bachelor's progressive experience in all of the following: Risk Mgmt. Deliverables including Use, Design and Process FMEA, and Product Hazard Analysis; Design Control Deliverables to include Product Performance Specifications, Design Verification, Design Validation, and Design Transfer, and Usability and Human Factor Engineering; Complaint and Product Failure Investigations, pre and post market root cause analysis, CAPA, and Product Non-Conformances; FDA 21 CFR 820, ISO 13485, and ISO 14971 European Union (EU) Medical Device Regulation (MDR), and State of the Art (SOTA); Application of statistics for risk estimation.

Position reports to Medtronic, Inc. 7000 Central Ave NE, Fridley, MN 55432

Salary: $120,200.00 to $152,400.00 per year

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

Use this link to hyperlink

_https://www3.benefitsolver.com/benefits/BenefitSolverView?page\_name=signon&co\_num=30601&co\_affid=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 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, 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 law. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities.

For sales reps and other patient facing field employees, going into a healthcare setting is considered an essential function of the job and we expect our employees to comply with all credentialing requirements at the hospitals or clinics they support.

This employer participates in the federal E-Verify program to confirm the identity and employment authorization of all newly hired employees. For further information about the E-Verify program, please click here (https://www.e-verify.gov/employees) .

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