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About the role
- Senior Software Engineering Program Manager at Medtronic driving enterprise-wide quality initiatives and managing cross-functional teams. Focus on software design control and compliance in medical technology.
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.
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)
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