Kelly Ashfield

Director of Program Management and San Francisco Site Operations, Ximedica

Kelly Ashfield

Director of Program Management and San Francisco Site Operations, Ximedica

Biography

In her role as Director of Program Management and Site Operations, Kelly maintains responsibility for Ximedica’s San Francisco office and ensures program success by providing strategic guidance to clients, program managers and teams throughout the development process. With over 15 years’ experience in the medical device industry, Kelly has a strong background in managing project teams throughout the entire product development cycle from initial concept through launch.

Kelly collaborates with prospective clients to understand their needs to ensure team alignment in accordance with client goals and expectations and maintains a perspective as a client advocate throughout the project. She is particularly skilled at facilitating the identification of market and user needs, as well as translating that information to actionable product requirements and project plans.

Kelly also has a strong background in Quality, as the previous Director of Quality Services at Ximedica, and with an in-depth knowledge of ISO 13485, 21 CFR 820 and a variety of other regulations, is uniquely positioned to offer insight and guidance on tailored development pathways to ensure compliance alongside achieving business and market goals.
Kelly holds a Bachelor of Science in Biomedical Engineering from Rensselaer Polytechnic Institute and a Master of Business Administration (MBA) from the University of Rhode Island.

All session by Kelly Ashfield