Principal Software Quality Engineer - Infrastructure/Post‑Market
About The Position
At Medtronic, 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 a minimum of 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. Join Medtronic as a Principal Software Quality Engineer - Infrastructure/Post-Market, and take a leading role in ensuring the safety, reliability, and compliance integrity of Affera cardiac electrophysiology systems software used in live clinical environments worldwide. In this high-impact position, you will drive complex issue evaluations and health risk analyses based on real ‑ world device performance. This role partners closely with field staff observing issues, customer quality experience (CQXM) and quality trending personnel, Software Quality and R&D Engineers from product teams, Medical Safety, and Clinical teams to analyze software behavior observed in the field, assess risk, and guide high‑impact post‑market decisions and actions. As a technical and compliance authority, you will shape investigation quality, assessment rigor, product reliability, and regulatory audit readiness as Affera adoption continues to expand globally.
Requirements
- Bachelor's degree and a minimum of 7 years of relevant experience OR Master’s degree with a minimum of 5 years of relevant experience OR PhD with 3 years relevant experience
- Ability to secure hospital credentialing for clinical site visits.
Nice To Haves
- Bachelor’s degree in software engineering, computer engineering, electrical engineering, biomedical engineering, or a related technical field.
- 7+ years of experience in software quality, reliability engineering, post ‑ market surveillance, software engineering, or regulated medical device development
- Strong working knowledge of medical device quality systems and regulations, including FDA CFR, MDR, ISO 13485, and IEC 62304.
- Ability to read, interpret, and evaluate software behavior, logs, and technical data to support investigations.
- Excellent analytical and written/oral communication skills.
- Experience supporting post ‑ market surveillance or activities for complex medical device software on capital equipment.
- Experience leading post ‑ market software issue evaluations, risk assessments, and CAPA activities.
- Experience working with risk analysis documentation such as FMEAs and FTAs.
- Experience working with cardiac electrophysiology medical devices.
- Skilled in program management and work/metric tracking across complex systems and multiple products.
- Advanced degree in a relevant technical or quality discipline.
- Quality or regulatory certifications (ASQ, Six Sigma, or similar).
Responsibilities
- Build and maintain deep system ‑ level understanding of Affera software performance in clinical use through regular engagement in live case observations.
- Lead and execute post ‑ market software issue evaluations, including complaint analysis, risk file assessments, and impact determination.
- Serve as a principal author of Health Risk Assessments (HRAs) for software anomalies and corrections, ensuring clear linkage between observed software behavior, risk files, and system ‑ level impacts.
- Act as a quality and compliance authority for selected software ‑ related CAPAs, guiding root cause analysis, mitigation strategy development, and verification of effectiveness.
- Author, review, and approve post ‑ market quality system documentation, including issue evaluations, CAPA records, risk file updates, and field action support materials.
- Drive software field corrective action intake and follow-on actions for the CAS OU.
- Ensure post ‑ market documentation is audit ‑ ready, technically defensible, and aligned with FDA, EU MDR, and global regulatory expectations.
- Partner closely with cross ‑ functional teams to track metrics that drive timely and compliant resolution of software issues.
- Provide program management/coordination support, technical mentorship, and strategic guidance to other engineers supporting complaint handling, investigations, and post ‑ market surveillance activities.
- Influence enterprise ‑ level post ‑ market software quality processes as needed.
- Represent post ‑ market software quality during inspections, audits, and internal reviews, providing preparation support, clear technical and regulatory rationales, and assistance.
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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What This Job Offers
Job Type
Full-time
Career Level
Principal
