Senior Post-Market Software Quality Engineer – Infra

We anticipate the application window for this opening will close on - 15 Jun 2026.

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.

• 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.

• 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

• 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.
• 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).

For Baccalaureate degrees earned outside of the United States, a degree that satisfies the requirements of 8 C.F.R.
214.2(h)(4)(iii)(A) is required.

The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position. The physical demands described within the Responsibilities section of this job…