Medtronic

Senior Software Engineering Program Manager, Design Quality

Medtronic

full-time

Posted on:

Location Type: Hybrid

Location: Mounds View • Arizona • Colorado • United States

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Salary

💰 $149,600 - $224,400 per year

Job Level

Senior

About the role

  • 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.

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
  • 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.
Benefits
  • 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)
Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools
Design for ReliabilityDesign for ManufacturabilityProduct Development ProcessCAPAPost-Market SurveillanceSystems EngineeringStatistical MethodsSoftware Development Life CycleProcess ValidationRisk Management
Soft Skills
Effective PlanningOrganization SkillsCommunication SkillsAnalytical SkillsInfluencing SkillsInterpersonal SkillsCoachingDecision-MakingStakeholder ManagementCross-Functional Team Leadership
Certifications
Green Belt Six SigmaASQ (CSQE)INCOSEIEEE (PSEM, CSDP)CSSLPCSM (Scrum Master)DRM TrainingISO 13485 CertificationIEC 62304 CertificationIEC 81001-5-1 Certification