Senior Principal Reliability Engineer
Mounds View, MN - USA
Job Summary
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
At Medtronic we push the limits of what technology can do to make tomorrow better than yesterday and that makes it an exciting and rewarding place to work. We value what makes you unique. Be a part of a company that thinks differently to solve problems make progress and deliver meaningful innovations.The Cardiac Surgery Operating Unit develops and delivers innovative surgical solutions that enable surgeons to treat complex heart conditions including coronary artery disease structural heart disease and cardiopulmonary support needs.
In this exciting role as a Senior Principal Reliability Engineer in the Post Market Quality organization you will provide technical and strategic leadership across all aspects of quality related to the commercial product portfolio including Health Risk Assessments Post Market Surveillance and Risk Management. You will serve as a key partner to cross functional teams guiding critical quality decisions that protect patients and ensure sustained product performance.
At Medtronic we bring bold ideas forward with speed and decisiveness to put patients first in everything we -person exchanges are invaluable to our work. We are working onsite a minimum of 4 days per week as part of our commitment to fostering a culture of professional growth and cross-functional collaboration as we work together to engineer the extraordinary. This role will require less than 10% of travel to enhance collaboration and ensure successful completion of projects.
This position is based in Mounds View MN.
Responsibilities may include the following and other duties may be assigned:
- Enterprise Risk & Patient Safety Leadership:Lead portfolio-level risk management and Health Risk Assessments using post-market data; advise senior leadership on patient risk business impact and Field Corrective Action (FCA) decisions.
- Post-Market Surveillance Strategy:Define and drive enterprise post-market reliability surveillance strategies advanced analytics and early warning indicators across multiple products or platforms.
- Complex Failure Analysis & Investigations:Serve as technical authority for high-impact failure investigations and complaint trend excursions applying advanced root cause and system-level analysis methods.
- Regulatory & External Engagement:Act as a subject-matter expert in regulatory interactions; author and review critical technical and regulatory documentation ensuring compliance with global regulations and standards.
- Cross-Functional Reliability Improvement:Lead and influence cross-functional corrective and preventive actions to address systemic reliability risks across design manufacturing suppliers and lifecycle management.
- Technical Leadership & Mentorship:Mentor and develop senior technical talent; establish and propagate engineering best practices and standards across the organization.
- Executive & Customer Communication:Translate complex reliability and risk information into clear actionable insights for executive leadership customers and field organizations.
Nice to Have
- Extensive experience in the medical device industry with demonstrated impact across product development manufacturing or quality organizations.
- Recognized subjectmatter expertise in risk management including advanced application of ISO 14971 in postmarket risk evaluation.
- Proven leadership in complex highvisibility failure investigations Health Risk Assessments and field actions.
- Strong executivelevel communication and technical writing skills with the ability to translate complex reliability and risk topics for diverse stakeholders including regulatory authorities.
- Advanced analytical skills including statistical analysis of postmarket data and application of systemlevel reliability methodologies.
- Demonstrated ability to mentor senior engineers and shape reliability engineering practices standards and strategy across an organization.
Requirements:
- Requires a Baccalaureate degreeand minimum of 10 years of relevant experience
OR
- Masters degree with a minimum of 8 years relevant experience
OR
- PhD with 6 years relevant experience
For Baccalaureate degrees earned outside of the United States a degree that satisfies the requirements of 8 C.F.R. 214.2(h)(4)(iii)(A) is required.
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.
U.S. Work Authorization & Sponsorship
At Medtronic we are committed to fostering an environment where employees can thrive and make a meaningful alignment with our enterprise-wide workforce planning approach U.S. work authorization sponsorship (H-1B TN J etc.) is offered exclusively for Principal-level roles and above where specialized expertise aligns with long-term business needs. Roles below the Principal level require candidates to possess unrestricted U.S. work authorization at the time of hire and for the duration of employment.
Join us in our mission to alleviate pain restore health and extend lifewhere your unique background and perspective are valued.
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.
If you are applying to perform work for Medtronic Inc. (Medtronic) in any position which will involve performing at least two (2) hours of work on average each week within the unincorporated areas of Los Angeles County you can findhere a list of all material job duties of the specific job position which Medtronic reasonably believes that criminal history may have a direct adverse and negative relationship potentially resulting in the withdrawal of a conditional offer of employment. Medtronic will consider for employment qualified job applicants with arrest or conviction records in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act.
Required Experience:
Staff IC
About Company
About Medtronic Together, we can change healthcare worldwide. At Medtronic, we push the limits of what technology can do to help alleviate pain, restore health and extend life. We challenge ourselves and each other to make tomorrow better than yesterday. It is what makes this an excit ... View more