Summary
Kevin Higgs is a Principal Software Quality Engineer with over 10 years’ experience in medical device and clinical genomics software, currently leading quality engineering at Medtronic Digital Surgery. He has deep expertise in ISO 13485, IEC 62304, ISO 14971 and regulatory strategy for CE/FDA submissions, having managed QMS and information security for Congenica and chaired post-market surveillance and senior management quality meetings. Kevin combines hands‑on software and systems integration background—from embedded C#, Delphi and LabVIEW to SQL and test automation—with a strong history of audits, supplier oversight and computer system validation to GAMP5. He has led cross-border manufacturing transitions and compliance projects in China and Europe, blending pragmatic engineering with regulatory rigor to get complex medical software into clinical use. Notably, he serves as a senior information risk owner and has longstanding experience interfacing with regulators (FDA, MHRA) to shape compliant product lifecycles.
10 years of coding experience
41 years of employment as a software developer
Electronic Engineering Electronics & Software Engineering, Electronic Engineering Electronics & Software Engineering at University of Brighton