Title: Senior Software Safety Engineer - CRM Location: Minneapolis, Minnesota, United States of America Job Description: 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 Senior Software Safety Engineer Careers That Change Lives 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 Rhythm Management (CRM) Operating Unit offers devices and therapies that treat patients with abnormal heart rhythms and heart failure. We are comprised of three businesses: • Cardiac Pacing Therapies • Cardiovascular Diagnostics & Services • Defibrillation Solutions We put people first in all we do as we remain on the leading edge of innovation to ensure that we treat more people year after year. We excel in how we operate to deliver the best experiences for people who touch our therapies. Join Our Mission to Revolutionize Patient Safety as a Senior Software Safety Engineer! In this exciting role as a Senior Software Safety Engineer, you will have responsibility for ensuring our software products exceed the safety and reliability requirements and expectations of patients, clinicians, regulators, and the business. Are you ready to make a meaningful impact on lives while working at the forefront of medical innovation? As a Senior Software Safety Engineer at Medtronic, you’ll play a critical role in designing and shaping cutting-edge cardiac rhythm management products that improve patient outcomes worldwide. This is your chance to collaborate with diverse, cross-functional teams—including product development, software reliability, cybersecurity, human research development, medical safety, and regulatory bodies—to ensure our products meet the highest safety and performance standards. Your expertise will directly influence the development, production, and market release of life-saving technologies. In this exciting role, you’ll: • Identify and mitigate patient safety hazards within Medtronic software, working closely with medical safety teams to evaluate device safety from a clinical perspective. • Ensure risk management files are meticulously developed and maintained in compliance with ISO 13485, ISO 14971, and IEC 62304 standards, while providing critical feedback during the design input and output phases. • Lead efforts to trace design validation and verification in risk management files, ensuring every safety measure aligns with global standards. • Recommend innovative risk mitigations and deliver data-driven risk-versus-benefit analyses to project stakeholders, always keeping patient safety as the top priority. If you thrive in a fast-paced, collaborative environment and are passionate about advancing healthcare through technology, this is the perfect opportunity for you to make a lasting impact. Join us in shaping the future of cardiac rhythm management and become a key driver in Medtronic’s mission to transform lives. We believe that when people from different cultures, genders, and points of view come together, innovation is the result —and everyone wins. Medtronic walks the walk, creating an inclusive culture where you can thrive. This position is fully remote within the Cardiac Rhythm Management (CRM) Operating Unit. At Medtronic, we bring bold ideas forward with speed and decisiveness to put patients first in everything we do. While we value in-person collaboration, this role is designed to support a remote-first work environment, leveraging virtual tools and intentional communication to foster strong cross-functional partnerships and professional growth. Occasional travel (less than 10%) may be required to support key meetings, strengthen team connections, and ensure successful project execution. A Day in the Life In general, the following responsibilities apply for the Senior Software Safety Engineer role. This includes, but is not limited to the following: - Leverages relevant field experience and/or clinical knowledge to ensure the practical applicability and safety of our products in real-world settings. - Completes risk severity and occurrence determination and analyze risk benefit profiles for cardiac medical products. - Completes risk analysis studies of new design and processes. - Compiles and analyzes performance reports and process control statistics; investigates and analyzes relevant variables potentially affecting product and processes. - Ensures that corrective measures meet acceptable reliability standards. - Analyzes preliminary plans and develops reliability/safety engineering programs to achieve company, customer and governmental agency reliability/safety objectives. - Develops, coordinates and conducts technical reliability/safety studies and evaluations of engineering design concepts and design of experiments (DOE) constructs. - Recommends design or test methods and statistical process control procedures for achieving required levels of product reliability and safety. - Proposes changes in design or formulation to improve system and/or process reliability and product safety. Specialized Knowledge Required: - One or more of following qualifications: - Medical doctor with related device experience - Engineer who has achieved IBHRE or NASPE Exam certification - Personnel with at least 5 years of clinical field experience in the past 15 years. The relevant field experience could include the following: - Nurse - Field Personnel such as: Clinical Specialist, Technical Field Educator, Field - Clinical Engineer - Technical Services (cardiac products) - Personnel with at least 5 years of previous clinical experience related to cardiac therapy products. Qualifications Must Have - Minimum Requirements TO BE CONSIDERED FOR THIS ROLE, PLEASE BE SURE THE MINIMUM REQUIREMENTS ARE EVIDENT ON YOUR RESUME - Bachelor’s degree in Science, Technology, Engineering, Math or a related technical discipline and a minimum of 4 years of technical experience OR a Master's degree with a minimum of 2 years technical experience Nice to Have - Experience in a highly regulated industry, preferably implantable medical devices  - Advanced degree in Engineering or suitable Clinical/Field Support, Safety or Reliability Engineering, Biomedical Engineering, software development / test, or Product Development Engineering experience - Experience with 21 CFR Part 820 (Quality System Regulation), ISO 13485, ISO 14971, and Hazard Analysis and Risk Analysis techniques (e.g., FTA, DFMEA, Hazard Analysis Logs, Risk Management Report & Files), IEC 62304 / 82304. - Strong written and verbal communication skills and ability to work cooperatively and influence outcomes as part of a cross-functional team - Ability to manage project timelines to execute tasks and deliverables in a timely manner - Experience in the design, maintenance, or continuation engineering of released software or software systems, including mobile applications - Knowledge of Software Development Live Cycle (SDLC), Design for Reliability (DfR), Design for Reliability and Manufacturability (DRM), Design for Six Sigma (DFSS), Design for Lean Sigma (DFLS), and/or robust design practices - Previous clinical field experience, specifically with cardiac rhythm management products. About Medtronic Together, we can change healthcare worldwide. At Medtronic, we push the limits of what technology, therapies and services can do to help alleviate pain, restore health, and extend life. We challenge ourselves and each other to make tomorrow better than yesterday. It is what makes this an exciting and rewarding place to be. We want to accelerate and advance our ability to create meaningful innovations - but we will only succeed with the right people on our team. Let’s work together to address universal healthcare needs and improve patients’ lives. Help us shape the future. Physical Job Requirements PHYSICAL JOB REQUIREMENTS - 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 accommodation 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. (ADA-United States of America) 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 Requirements The 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 & Compensation 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, andSimple 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), andCapital 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 About Medtronic 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. 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. If you are applying to perform work for Medtronic, Inc. (“Medtronic”) in any position which will involve performing at least two (2) hours of work on average each week within the unincorporated areas of Los Angeles County, you can find here a list of all material job duties of the specific job position which Medtronic reasonably believes that criminal history may have a direct, adverse and negative relationship potentially resulting in the withdrawal of a conditional offer of employment. Medtronic will consider for employment qualified job applicants with arrest or conviction records in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act.