Principal Reliability Engineer - CRM
About The Position
Careers that change lives start here. Medtronic is a global leader in healthcare technology with a Mission to alleviate pain, restore health, and extend life. Our 95,000 employees work across more than 150 countries to put patients first — developing innovative medical technologies that improve the lives of 72+ million patients each year. Your unique talents will help shape the future of healthcare while building a career grounded in purpose, growth, and impact. A Day in the Life Principal Reliability Engineer Careers That Change Lives 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 Rhythm Management (CRM) Operating Unit offers devices and therapies that treat patients with abnormal heart rhythms and heart failure. We are comprised of three businesses: Cardiac Pacing Therapies, Cardiovascular Diagnostics & Services, and Defibrillation Solutions. We put people first in all we do as we remain on the leading edge of innovation to ensure that we treat more people year after year. We excel in how we operate to deliver the best experiences for people who touch our therapies. In this exciting role as a Post Market Principal Reliability Engineer, you will have responsibility for ensuring our Cardiac Ablation Solutions (CAS) products exceed the safety and reliability requirements and expectations of patients, clinicians, regulators, and the business. This position is in Mounds View, MN. within the Cardiac Rhythm Management (CRM) Operating Unit. At Medtronic, we bring bold ideas forward with speed and decisiveness to put patients first in everything we do. In-person exchanges are invaluable to our work. We are working on-site 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. We believe that when people from different cultures, genders, and points of view come together, innovation is the result —and everyone wins. Medtronic walks the walk, creating an inclusive culture where you can thrive.
Requirements
- Bachelor’s degree in science, technology, engineering, or math and minimum of 7 years of technical work experience OR advanced degree in with 5 years of technical work experience.
Nice To Haves
- Proficiency with data analysis using reliability tools and statistical techniques
- Manufacturing experience
- Implantable medical device industry experience
- Advanced degree in Engineering or suitable Clinical/Field Support, Safety or Reliability Engineering, Biomedical Engineering, Mechanical Design Engineering, or Product Development Engineering experience
- Experience with 21 CFR Part 820 (Quality System Regulation), ISO 13485, ISO 14971, and Hazard Analysis and Risk Analysis techniques (e.g., FTA, DFMEA, Hazard Analysis Logs, Risk Management Report & Files)
- Strong written and verbal communication skills and ability to work cooperatively and influence outcomes as part of a cross-functional team
- Ability to manage project timelines to execute tasks and deliverables in a timely manner
Responsibilities
- Lead reliability initiatives to address and resolve product-related issues, including those arising from manufacturing processes and field complaints.
- Provide support for Product Hold Orders (PHO) and Field Corrective Action (FCA) activities.
- Apply critical thinking skills to assess the necessity of additional actions and prepare audit-defensible rationales when further actions are deemed unnecessary.
- Ensure corrective actions align with established reliability standards and regulatory requirements.
- Conduct comprehensive risk analyses for new designs and processes to identify potential failure modes and mitigate risks.
- Lead design verification activities, including the development of test methods, sample size justification, and preparation of Engineering Build Requests.
- Oversee test method validation, utilizing appropriate statistical methodologies.
- Plan, coordinate, and execute technical reliability studies, engineering design evaluations, and design of experiments (DOE).
- Maintain ownership of Risk Management documentation (e.g., Risk Management Reports, Product Hazard Analyses, DFMEA), including project-specific risk assessments and issue analysis.
- Ensure risk management files are continuously updated to reflect current field performance for released products.
- May determine units and/or batches requiring environmental testing and specifies minimum number of samples to obtain statistically valid data.
Benefits
- 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
- 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)
- Capital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums)
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What This Job Offers
Job Type
Full-time
Career Level
Principal
