Principal Software Quality Engineer – Infrastructure/Post-Market

Medtronic

Principal Software Quality Engineer at Medtronic ensuring safety, reliability, and compliance of Affera software in clinical environments. Leading evaluations and guiding high-impact post-market decisions.

Posted 5/15/2026full-timeMounds View • Massachusetts, Minnesota • 🇺🇸 United StatesLead💰 $124,800 - $187,200 per yearWebsite

About the role

Key responsibilities & impact

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

Requirements

What you’ll need

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
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
Capability to secure hospital credentialing for clinical site visits
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)

Benefits

Comp & perks

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)

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

software qualityreliability engineeringpost-market surveillancerisk assessmentsCAPA activitiesrisk analysis documentationFMEAsFTAsmedical device quality systemssoftware behavior evaluation

Soft Skills

analytical skillswritten communicationoral communicationtechnical mentorshipstrategic guidanceprogram managementcollaborationproblem-solvinginfluenceleadership

Certifications

ASQSix Sigma