Software Design Quality Engineer
Core
Develop, maintain, and manage comprehensive software quality documentation and lead assessments of software designs to ensure regulatory compliance, safety, and quality throughout the medical device software lifecycle.
Role type
Senior Software Design Quality Engineer (Medical Devices)
Builds
Production medical device software systems compliant with FDA and IEC standards
Domain
Medical device software / Regulatory compliance / Quality Assurance
Deliverable
production ML models | product features | dashboards & analysis | client delivery | infrastructure | physical/clinical work
Required skills
Software Design Assurance, Risk Management (ISO 14971), Root Cause Analysis, Software V&V, Design Traceability, Regulatory Planning, Test Protocol Execution, Corrective Action Management, C/C++/C# code interpretation, Agile/SAFe methodologies
Preferred skills
ISTQB certification, Experience with complex medical systems (hardware/software/disposables), Knowledge of Design for Quality (DfQ)
Responsibilities
Lead assessment of software designs using test and performance data, Track and risk assess software anomalies for pre- and post-market devices, Conduct detailed root cause analyses for software quality issues, Implement software quality plans and risk management activities, Ensure compliance across the product software lifecycle by overseeing regulatory filings, Drive regulatory excellence by optimizing processes for efficiency
Seniority
Senior, hands-on IC with strategic regulatory oversight