Senior Reliability Engineer

We anticipate the application window for this opening will close on - 17 Jun 2026 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 LifeIn 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 teamNice to HavesPrior experience in the medical device industry across product development, operations, or quality functionsDemonstrated expertise in risk management in accordance with ISO 14971Strong technical writing and communication skills, with the ability to clearly explain complex technical topics to non-technical audiencesProven ability to lead root cause investigations, solve complex technical problems, and perform statistical data analysisKnowledge of Microsoft Office Applications (Word, Excel, and PowerPoint) and Windows OSFamiliarity with ISO 13485RequirementsRequires 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.Physical Job RequirementsThe 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 impact. In 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 life—where your unique background and perspective are valued. Benefits & Co