Senior Software Design Quality Engineer

Marlborough, MA · 1 month ago

$97,600 to $152,700 a year

About the job

Position Summary The Senior Software Design Quality Engineer serves as a senior Design Quality authority for software-enabled in-vitro diagnostics (IVD) medical devices across the development lifecycle. This includes software-enabled diagnostic systems incorporating image analysis and AI/ML-based algorithms to support detection and classification of cellular abnormalities. Embedded on New Product Development (NPD) core teams, this role owns software design controls, drives integration of ISO 14971 risk management into the software development lifecycle (SDLC), and ensures alignment to IEC 62304 and applicable Software as a Medical Device (SaMD) expectations. Post-market signals are...