Medical device leader with over twenty years of experience at startups and large companies. Experienced leader, engineer, and inventor creating teams that have launched multiple medical device products. Inventor of multiple "world's first" in micro electro-mechanical system (MEMS) medical devices. Selected accomplishments• Transformational Products: Joined ViaCyte as lead product concept, a living artificial pancreas, struggled in clinic circa 2016. In 2019, ViaCyte announced Type I diabetics have been producing measurable insulin de novo with PEC-Direct product in Phase I/II. Led engineering of both device and combination product from concept to this historic milestone. • Commercial Products: Launched three commercial 510k catheters at Covidien Neurovascular in concert with game-changing stent products. Launched two MEMS products at Microfabrica that prevented company from foundering.• Project Management: Managed over twenty development programs in total. Led turnaround of Covidien neurovascular catheter programs from repeated process validation failures to first-time, on-time success. • Change Agent: Co-developed Amgen’s first comprehensive device strategy across $11 billion device-dependent revenue. Transformed Microfabrica’s probe business from non-starter to profitability via design methods. • Design Innovation: Co-invented world’s first published all-MEMS surgery tool, per Journal of American College of Cardiology. Inventor of artificial pancreas devices, autoinjectors, IoT drug delivery, catheters, stents / delivery, microsurgery tools, and microfluidic pumps / valves. 25+ patents issued or pending.email: crfolk at gmail