Senior Software Engineering Program Manager, Design Quality Center of Expertise position at Medtronic plc.| United States Of America

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Medtronic plc Senior Software Engineering Program Manager, Design Quality Center of Expertise

Experience: 7-years

Pattern: full-time

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Mounds View, M..........United States Of America

We anticipate the application window for this opening will close on - 6 Feb 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 Life Join us at Medtronic, where we are partnering across the industry to tackle systemic healthcare challenges with bold leadership. If you seek a challenging, energizing, and rewarding career that changes lives, we invite you to join our team. Become part of the next generation of life-changing medical technology, impacting patients worldwide. The Senior Software Engineering Program Manager drives the evolution of Medtronic’s product development processes to set new industry-leading standards serving as a domain expert in Software Design Control. Lead our team by coaching internal customers across our diverse product portfolio, to elevate Software Design Control capabilities throughout the organization. In this role, you will proactively identify and implement large-scale initiatives that enhance rigor, productivity and user experience by leveraging cutting-edge technologies and innovative methodologies. At Medtronic, we must work with a sense of purpose and ownership, knowing there is a human life on the other side of every decision. 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’re working 4+ days a week onsite 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 position will be on-site , based at one of the following Medtronic North America sites: Mounds View, MN (Twin Cities Campus). Irvine, CA (Orange County Campus). Tempe, AZ. Lafayette, CO (Colorado Campus). Danvers, MA or Billerica, MA. Memphis, TN. Jacksonville, FL. Fort Worth, TX North Haven, CT Responsibilities may include the following and other duties may be assigned. Lead enterprise-wide initiatives with emphasis on Design, Reliability & Manufacturability/Maintainability (DRM) to ensure product quality, regulatory compliance and operational excellence across all Medtronic Operating Units (OU). Apply your technical expertise to Put Patients First every day. Apply Design for Reliability and Design for Manufacturability principles to reduce risk, improve First Time Quality (FTQ), and enable efficient design transfer. Guide cross-functional teams through the Product Development Process (PDP) with a strong focus on positive design control outcomes and regulatory adherence. Serve as a subject matter expert in CAPA and Post-Market Surveillance (PMS), ensuring field performance insights are incorporated into early design phases. Apply systems engineering principles to coordinate complex, multi-disciplinary product development efforts from concept through commercialization. Leverage biomedical engineering knowledge to ensure designs meet functional, safety, and efficacy requirements in compliance with medical device standards. Maintain deep familiarity with FDA 21 CFR Part 820, ISO 13485, IEC 62304, ISO14971 and other design control regulations, providing expert guidance on compliance throughout the development lifecycle. Partner closely with R&D and Quality colleagues to embed best practices in technical rigor, simplify execution, and bring forward individual perspectives that strengthen decision-making and solution design. Conduct / support software engineering capability assessments to drive continuous improvement initiatives and organizational knowledge sharing. Improve product quality, regulatory compliance, and operational excellence across all Operating Units (OUs). Serve as subject matter expert for: CAPA. Post‑Market Surveillance (PMS). Incorporation of field performance data into early design phases. Provide hands‑on coaching to engineering, quality, and cross‑functional teams to strengthen Software Design Control maturity across Medtronic. Must Have: Minimum Requirements To be considered for this role, please ensure the minimum requirements are evident in your applicant profile.   Bachelor’s Degree with 7+ years of work experience in Quality and/or Development, with 5+ years of managerial experience. OR Advanced Degree with 5+ years of work experience in Quality and/or Development, with 5+ years of managerial experience. Nice to Have: Preferred Qualifications Experience with traditional staged software development life cycles, as well as incremental / Agile development life cycles. Experience leading complex projects/programs. Experience with SPC, CAPA, NCMR, PDP processes. Effective planning and organization skills including the proven ability to work against multiple objectives simultaneously. Ability to establish and maintain a trusted role with the various stakeholders in coordinating multiple functions across the organization. Working knowledge of Quality System Regulations such as (QSR 21 CFR 820), and ISO 13485. Working knowledge of Software Development Standards such as IEC 62304, IEC 82304, and IEC 81001-5-1. Green Belt Six Sigma/DRM Training/Certification. Effective verbal and written communication, analytical, influencing and interpersonal skills. Demonstrated working knowledge of process validation, statistical methods, risk management, software engineering best practices. Experience with Software & Systems Reliability tools and methodologies (e.g. IEEE-1633). Experience with software capability assessment methodologies (e.g. CMMI, ISO/IEC 12207, ISO/IEC 15504, etc.). Relevant professional certifications (e.g. ASQ (CSQE), INCOSE, IEEE (PSEM, CSDP), CSSLP, CSM (Scrum Master), etc.). Experience in the application of artificial intelligence/machine learning tools and methods to software quality systems and software development life cycles. Experience in the application of secure software development lifecycles and frameworks. Strong communication and leadership skills with ability to influence without authority. Experience influencing large-scale process adoption across multiple OUs or business groups. 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. 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):$149,600.00 - $224,400.00 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 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.

Senior Software Engineering Program Manager, Design Quality Center of Expertise job opportunity at Medtronic plc.

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