We anticipate the application window for this opening will close on - 11 Apr 2025 Position Description: Sr. Software Design Quality Assurance Engineer for Medtronic, Inc. Minneapolis, MN. Support new product development group to drive the software development activities for digital health solutions. Responsible for mobile applications, data driven solutions and infrastructure services. Collaborate with core R&D to drive quality into software product development for products including Digital Health mobile apps and cloud-based systems such as CareLink. Engage as a quality core team member responsible for driving quality into the design and development of digital health solutions (medical mobile device applications (iOS/Android)/cloud technologies - AWS/AI/ML). Responsible for quality strategy for projects in alignment with business goals for cross-functional teams including R&D / Regulatory / Marketing / Operations. Drive quality focused design and development of SDLC software within the software development lifecycle (Agile/waterfall/DevOps) by defining the requirements, design, verification and validation plan and strategies while maintaining traceability. Participate in design reviews for the system for the review and approval of design input/design output artifacts including requirements, design documents, code review, test results, verification and validation reports and defects. Conduct risk activities including system risk analysis and software FMEAs. Drive CAPA (Corrective and Preventative Action) projects while participating in both internal and external regulatory audits and inspections. Drive quality improvement projects to include compliance standards for software quality operating methods, processes, and procedures including ISO13485, IEC62304, HIPAA, FDA, Security Standards, and Data Privacy. *Multiple positions available. **Position is open to telecommuting from anywhere in the United States. *** Employer will accept any suitable combination of education, training or experience. #LI-DNI. Basic Qualifications: Master’s degree in Chemistry, Computer Science, Computer Engineering, Software Engineering, or related engineering field and three (3) years of experience with mobile application development and testing. Experience must include three (3) years of post-Bachelor’s progressive experience in all of the following: Design and development of digital health solutions for medical mobile device applications (iOS/Android), cloud technologies – AWS and AI/ML; Working with R&D, Regulatory, Marketing, and Operations to ensure product quality and alignment with business goals; Design and development of software within the SDLC (software development lifecycle) including Agile, waterfall & DevOps by defining requirements, design, verification and validation plan and strategies while maintaining traceability; Design reviews for the system to include review and approval of design input/design output artifacts including requirements, design documents, code review, test results. Verification and validation reports and defects; Risk activities including system risk analysis and software FMEAs; CAPA and participating in internal and external regulatory audits and inspections; Quality improvement projects to include compliance standards for software quality operating methods, processes, and procedures including ISO13485, IEC62304, HIPAA, FDA, Security Standards, and Data Privacy. Alternate Qualifications: Bachelor’s degree in Chemistry, Computer Science, Computer Engineering, Software Engineering or related engineering field and five (5) years of experience with mobile application development and testing. Experience must include five (5) years of post-Bachelor’s progressive experience in all of the following: Design and development of digital health solutions for medical mobile device applications (iOS/Android), cloud technologies – AWS and AI/ML; Working with R&D, Regulatory, Marketing, and Operations to ensure product quality and alignment with business goals; Design and development of software within the SDLC (software development lifecycle) including Agile, waterfall & DevOps by defining requirements, design, verification and validation plan and strategies while maintaining traceability; Design reviews for the system to include review and approval of design input/design output artifacts including requirements, design documents, code review, test results. Verification and validation reports and defects; Risk activities including system risk analysis and software FMEAs; CAPA and participating in internal and external regulatory audits and inspections; Quality improvement projects to include compliance standards for software quality operating methods, processes, and procedures including ISO13485, IEC62304, HIPAA, FDA, Security Standards, and Data Privacy. The position reports to Medtronic, Inc., 710 Medtronic Parkway NE, Minneapolis, MN 55432 and is open to telecommuting from anywhere in the United States. Salary: $141,900 to $147,600 per year 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 (https://www3.benefitsolver.com/benefits/BenefitSolverView?page\_name=signon&co\_num=30601&co\_affid=medtronic) **Welcome to our new Careers Site!** **If you applied before July 22nd, please check your email for a notification from us providing you with instructions and a link to set up your new account and retain access to your current activity. If you do not see an email from us, please feel free to proceed with creating a new account.** 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 90,000+ 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 (https://www.e-verify.gov/employees) . For updates on job applications, please go to the candidate login page and sign in to check your application status. If you need assistance completing your application please email AskHR@medtronic.com To request removal of your personal information from our systems please email RS.HRCompliance@medtronic.com