Tom Fraites
Senior Director, Product Development @Yukon Medical, Llc
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WORK HISTORY
Senior Director, Product Development @Yukon Medical, Llc
Key member of the Yukon Medical Management Team, leading the Product Development function and providing strategic, clinical, analytical, and technical depth and leadership to the organization. Strong advocate for cross-functional problem-solving, prioritization of precious resources, and predictable performance for our customers and partners. • Identify and champion new business and product opportunities, particularly in high acuity adjacent spaces. Understand and articulate customer needs, then build the prototypes, business cases, and customer relationships to bring the opportunities to reality. • Recruit, develop, mentor, and support Project Engineers and Program Managers with varying levels of experience and diverse skill sets. Teach medical device product development, R&D functional excellence, and strong cross-functional teamwork. • Led the technical team to obtain US FDA 510(K) clearance under the ONB Product Code for Yukon Medical\'s Arisure Closed System Transfer Device (CSTD)(K201422; March 2021), a key element of the company product portfolio and near- and mid-term growth. • Built the complete Design History File for Yukon Medical ClearTip Swabs and facilitated launch of the product within six months from initial product concept freeze. • Vertically integrated critical medical device test capabilities by sourcing test equipment on secondary markets, then building and validating in-house test methods, resulting in significant R&D cost savings and greater technical control and agility.
EDUCATION
The Johns Hopkins University
Bachelor of Science (B.S.), Biomedical Engineering
University of Florida College of Medicine
Master of Science (M.S.), Medical Sciences - Genetics
University of Florida College of Medicine
Ph.D., Medical Sciences - Genetics
University of Florida - Warrington College of Business
MBA
Stanford University
Executive Course in Managing Innovation - Program in Biodesign
SKILLS
ABOUT TOM FRAITES
I’m an experienced regenerative medicine and medical device R&D executive with a track…
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