Vice President, Solution Engineering
Suttons Creek
Carolyn Dorgan, MS, BS
VP, Solution Engineering
Carolyn Dorgan is a recognized leader in combination product development and regulatory strategy, with more than 15 years of experience spanning the FDA, medical device, biologics, and pharmaceutical industries. As Vice President of Solution Engineering at Suttons Creek, she partners with clients to design and deliver strategic, cross-functional solutions that advance product development and regulatory excellence.
Before joining Suttons Creek, Carolyn served in leadership roles at the U.S. Food and Drug Administration, where she guided global policy and standards for infusion and drug delivery devices. Her work has influenced international standards, shaped regulatory expectations, and improved patient safety across the industry.
Carolyn holds a BS in Biomedical Engineering from the University of Minnesota and an MS in Technology Commercialization from the University of Texas at Austin. She also completed executive leadership training at The Wharton School. A frequent speaker at industry conferences, she is known for translating complex technical and regulatory challenges into practical, business-focused strategies that drive innovation and compliance.
Navigating Clinical Strategies for Combination Products with Investigational Devices
Friday, November 14, 2025
1:15 PM - 2:30 PM East Coast USA Time