Senior Software Engineering Program Manager, Design Quality Center of Expertise

Medtronic•Tempe, MN

4d•Onsite

About The Position

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

Requirements

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 Haves

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.

Responsibilities

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.

Benefits

Medtronic offers a competitive Salary and flexible Benefits Package
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
Simple Steps (global well-being program)
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)
Capital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums)