This individual will take a holistic, end-to-end view of design quality, working across Software Engineering, R&D, Systems, Quality, Regulatory, and other cross-functional teams to assess design processes, identify gaps, and drive sustainable remediation. The ideal candidate brings a strong quality and design assurance mindset and is comfortable walking through a product from a risk and design perspective - understanding the relationship between risk assessment, design controls, requirements, architecture, implementation, verification, validation, and the DHF.