Design Quality Engineer, Software Remediation, Software Quality, Medical Device, Design Controls, IEC 62304, Design History File, DHF, Risk Management, CAPA, FDA, ISO 13485, Requirements, Verification and Validation, Traceability, Design Assurance, Quality Engineering, Systems Engineering, Medical Device Software. This position requires a holistic, end-to-end approach to design quality, connecting risk management, design controls, design inputs, requirements, design outputs, implementation, verification and validation, traceability, and the Design History File (DHF).