Principal Software Quality Engineer - Infrastructure​/Post‑Market

We anticipate the application window for this opening will close on - 15 Jun 2026 At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You'll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world. A Day in the Life 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. Primary 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.
* Travel Requirement: