Senior Software Engineering Program Manager, Design Quality Center of Expertise

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.

• 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.

• 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, ISO
  14971 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.

• 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.

• 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…