Principal Software Quality Engineer – Infrastructure​/Post-Market

Responsibilities

• Build and maintain deep systems‑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.
• 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).