Principal Reliability Engineer – Software Quality

We anticipate the application window for this opening will close on - 5 Aug 2026 Position Description: Principal Reliability Engineer- Software Quality for Covidien, LP. Responsible for various software quality assurance functions during the Product Development Process (PDP) development lifecycle of complex medical devices to identify software problems and their causes in partnership with Software Developers and Testers. Provide coordination to cross functional groups to ensure software quality objectives are met for product software, manufacturing software, quality system software and software technologies included or used in the creation or production of medical devices. Coordinate Medical Device Product Development (MDPD) and SDLC (Software Development Life Cycle) including navigating complex government and industry regulations including FDA 21 CFR Part 11 and Part 820, ISO 13485, ISO 14971, and IEC 62304. Utilize the Association for the Advancement of Medical Instrumentation (AAMI TIR45) to understand and work with various programming languages including C, C++, C#, Python and SQL. Utilize Minitab software packages for statistical analysis, process improvement, and quality control. Define and implement software quality metrics for tracking software progress and quality throughout the development process. Leverage reliability tools including Software Failure Mode Effect Analysis and Software Fault Tree Analysis (SFMEAs and SFTAs). Leverage practices that effectively support software requirements for product software design, integration and verification, validation, and prediction. Review, analyze and disposition Software Defects and Software Problem Reports (SPRs). Coordinate software validation processes including Software Cybersecurity, Medical Device Design Controls, Design History File and Product Life Cycle. Responsible for software validation, test methods development, automation testing, verification and validation (V&V) of product software. Relocation assistance is not available for this position. Position works a hybrid model and will be onsite in Boston, MA – 4 days per week. #LI-DNI Basic Qualifications: Bachelors' Degree in Information Technology, Computer Science, Software Engineering or related technical or engineering field and seven (7) years of experience as a software engineer or related occupation in software engineering or Master's Degree in Information Technology, Computer Science, Software Engineering or related technical or engineering field and five (5) years of experience as a software engineer or related occupation engineering. Must possess at least five (5) years of experience with each of the following: Coordination of cross functional groups for quality objectives around product software, quality system , and software technologies for medical devices; MDPD, SDLC, FDA 21 CFR Part 11 and Part 820, ISO 13485, ISO 14971, and IEC 62304; AAMI TIR45, C, C++, C#, Python and SQL; Minitab; SFMEA and SFTA; Review, analyze, and disposition of Software Defects and Software Problem Reports (SPRs); Software validation processes including Software Cybersecurity, Medical Device Design Controls, Design History File and Product Life Cycle; and Software validation, Test Methods Development, Automation testing, & V&V of product software. Salary: $140,600 to $198,000 per year #LI-DNI 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 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. We change lives. Each team member, each day, helps to improve and redefine how the world treats the most pressing health conditions, from heart disease to diabetes. Our industry leadership comes from the passion and ingenuity of our people. That's who we are. Working alongside one another, we use science, medicine, and a profound understanding of the human body to build extraordinary technologies that can transform lives. We build extraordinary solutions as one team. With one Medtronic Mindset defining how we work. Speed and decisiveness run through our DNA. Diverse perspectives inspire our bold answers to any challenge that comes our way. And we deliver results the right way, breakthrough after patient breakthrough. This life-changing career is yours to engineer. By bringing your ambitious ideas, unique perspective and contributions, you will… Build a better future, amplifying your impact on the causes that matter to you and the world Grow a career reflective of your passion and abilities Connect to a dynamic and inclusive culture that welcomes the challenge of life-long learning These commitments set our team apart from the rest: Experiences that put people first. Respect for people is the hallmark of our humanity. It fuels our team to positively impact even a single life. And it means we put our people first at Medtronic as well, creating a culture of belonging and always pushing to get you the career-building resources you need. Life-transforming technologies. No matter your role, you contribute to technologies that transform lives. What we build empowers patients to live life on their terms. Better outcomes for our world. Here, it's about more than the bottom line. Our Mission to improve human welfare drives us. We advance healthcare, society, and equity with every design, inside and outside our walls. Insight-driven care. Fresh viewpoints. Cutting-edge AI, data, and automation. You're shaping the future of healthcare technology and defining the next generation of breakthroughs in care 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 law. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities. For sales reps and other patient facing field employees, going into a healthcare setting is considered an essential function of the job and we expect our employees to comply with all credentialing requirements at the hospitals or clinics they support. This employer participates in the federal E-Verify program to confirm the identity and employment authorization of all newly hired employees. For further information about the E-Verify program, please click here. For updates on job applications, please go to the candidate login page and sign in to check your application status.