Principal Reliability Engineer

MedtronicMounds View, MN
3dOnsite

About The Position

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 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 Principal Reliability Engineer supporting the Post Market Quality organization, you will provide technical leadership across all quality aspects of the commercial 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 do. In-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.

Requirements

  • Requires a Baccalaureate degree in Science, Technology, Engineering, Math or a related technical discipline with a minimum of 7 years of relevant experience OR Master's degree with a minimum of 5 years relevant experience OR PhD with 3 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.

Nice To Haves

  • Prior experience in the medical device industry across product development, operations, or quality functions.
  • Demonstrated expertise in risk management in accordance with ISO 14971.
  • Strong technical writing and communication skills, with the ability to clearly explain complex technical topics to non-technical audiences.
  • Proven ability to lead root cause investigations, solve complex technical problems, and perform statistical data analysis.

Responsibilities

  • Risk Management: Support risk assessments and hazard analyses based on post-market data. Lead Health Risk Assessments to determine potential risk and recommend need for Field Corrective Action (FCA).
  • Post-Market Surveillance: Monitor product performance in the field, collect and analyze reliability data, and identify trends and potential issues.
  • Root Cause Investigation and Failure Analysis: Lead investigations into product failures and complaints, utilizing root cause analysis techniques to determine underlying causes. Support complaint trending and investigations of complaint trend excursions or quality signals from the field.
  • Design Control: Assess design and risk impacts of changes; generate, review, and approve FMEAs, test method validations, and verification and validation test reports in compliance with medical device design control requirements.
  • Continuous Improvement: Collaborate with design, manufacturing, and quality teams to implement design, process or supplier changes, corrective and preventive actions that enhance product reliability.
  • Customer Interaction: Provide technical support to customers and field personnel regarding reliability issues and product performance.
  • Coaching: Provide technical mentorship and coaching to junior engineers.

Benefits

  • Medtronic offers a competitive Salary and flexible Benefits Package
  • We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage.
  • 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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