Team

Carolyn Dorgan

Vice President, Solutions Engineering

Carolyn Dorgan is an influential and adaptive leader with 15+ years of experience spanning the FDA, medical device, biologics, and combination product industries. As Director of Technical Services at Suttons Creek, she leads cross-functional teams and guides clients through complex regulatory, quality, and organizational challenges—driving alignment and action across diverse functions and cultures. 

Previously, Carolyn served in various leadership roles at the U.S. Food and Drug Administration (FDA), where she led the Infusion Devices team and shaped international standards for drug delivery, injection systems, and pediatric medical devices. She is recognized globally as an inspiring voice in combination product development, frequently speaking at international conferences and contributing to over a dozen standards & guidance documents. 

Carolyn holds a BS in Biomedical Engineering from the University of Minnesota and an MS in Technology Commercialization from the University of Texas. She builds upon her engineering and commercialization degrees with executive leadership training from The Wharton School, bringing a rare blend of technical expertise, business acumen, and influential presence to her work.