Sr. Software Quality Engineer (Reliability/Compliance)
Core
Senior Software Quality Engineer ensuring regulatory compliance and reliability for Affera cardiac electrophysiology systems.
Role type
Senior IC software quality engineer (medical device)
Builds
Software for cardiac ablation solutions (mapping and navigation)
Domain
Healthcare / Medical Devices / Cardiac Electrophysiology
Deliverable
production ML models | product features | dashboards & analysis
Required skills
Regulatory compliance (FDA CFR, MDR, IEC 62304, ISO 13485), risk analysis (FMEA, FTA), software lifecycle management, QMS documentation, cross-functional collaboration, Python/Qt/Docker/Linux familiarity, cybersecurity knowledge
Preferred skills
Cardiac/EP specialty experience, Six Sigma/ASQ certification, 2+ years in regulated industry, 2+ years with software dev teams
Technologies
Python, Qt, Docker, Linux
Responsibilities
Review and approve Design History File documents for software and security; Develop traceability and compliance documentation; Participate in software risk analysis and defect assessments; Contribute to tracking software quality metrics; Provide support for post-market activities and CAPAs; Recommend design or test methods to improve reliability; Attend live EP cases to enhance product knowledge
Seniority
Senior, hands-on IC
