Senior Reliability Engineer

In this exciting role as a Senior Reliability Engineer supporting released products within the Cardiac Ablation Solutions Operating Unit, you will provide technical leadership across all quality aspects of the commercial portfolio, including Health Risk Assessments, Post Market Surveillance, and Risk Management. This role will serve as a key partner to cross functional teams, guiding critical quality decisions that protect patients and ensure sustained product performance.

Cardiac Ablation Solutions offers cardiac mapping and ablation solutions to treat patients with abnormal heart rhythms. It is focused on disrupting and leading the market with advanced ablation catheters, cardiac mapping systems, and conventional EP products.

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.

Responsibilities may include the following and other duties may be assigned:

• 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). Update Risk Management files (Risk Management Report, Hazard Analysis, DFMEA, etc.) including risk assessments for trending breaches, design and manufacturing issues, and projects.

• Post-Market Activities: Create responses to Regulatory Inquiries, Issue Evaluations, Health Risk Assessments, and any general risk related questions. Author Periodic Safety Update Reports (PSURs). Analyze reliability data and identify trends and potential issues. Own CAPA investigations, corrective actions, and collaborate with cross functional team to resolve technical issues.

• Root Cause Investigation: Lead investigations into product failures, 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 process changes for potential risk impacts. Generate, review, and approve FMEAs and design verification 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.

• Critical Thinking: Determine the need for further action or to document defendable rationales when no further actions are required. Demonstrate strong written and verbal communication skills.

• Coaching: Provide technical mentorship and coaching to junior engineers. Work cooperatively as part of a global, cross-functional team

Do you have experience in Windows?, * 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
• Knowledge of Microsoft Office Applications (Word, Excel, and PowerPoint) and Windows OS
• Familiarity with ISO 13485

Requirements

• Requires a Baccalaureate degree in Science, Technology, Engineering, Math or a related technical discipline with a minimum of 4 years of relevant experience

OR

• Advanced degree with a minimum of 2 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.

3.83.8 out of 5 stars Mounds View, MN $107,200 - $160,800 a year - Full-time, Pulled from the full job description

• Tuition reimbursement
• Employee stock purchase plan
• 401(k)
• 401(k) matching
• Paid time off
• Vision insurance
• Health savings account, 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):$107,200.00 - $160,800.00

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

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., 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.

Learn more about our business, mission, and our commitment to diversity here .