Kelly Ashfield

Director of Program Management, Ximedica

Kelly Ashfield

Director of Program Management, Ximedica

Biography

In her role as Director of Program Management, Kelly works with a multidisciplinary team at all stages of the product development process to ensure compliance to overall Quality Systems, as well as client and regulatory requirements. She helps the team to establish the system design specifications and product requirements as well as manage overall project risk management activities, including leading Failure Mode and Effects Analysis (FMEA) activities. With over 10 years in the medical device industry, Kelly has a strong background in quality systems, new product development, and managing project teams from initial concept through market launch. She has experience in transferring new processes to manufacturing, 510(k) submissions, process improvement initiatives, and product acquisitions. Kelly holds a Bachelor of Science in Biomedical Engineering (mechanical concentration) from Rensselaer Polytechnic Institute and a

Master of Business Administration (MBA) from University of Rhode Island.