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
- 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.
- Capability 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
- 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
