Senior Software Design Quality Engineer

Senior Software Design Quality Engineer

Marlborough, MA, United States

**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 leveraged as structured inputs to design improvements. Ensures traceability and alignment across design inputs, verification, and validation to meet regulatory expectations under all applicable design...