Ms. Masters is a medical device development expert and has more than 20 years of experience in product development as a project manager, systems engineer and design engineer, serving as the project manager and lead systems engineer on medical device development and sustaining engineering programs. Capabilities include leading a large multi-disciplinary team, leading risk assessments, creation of design inputs, design, specification creation, design verification, task management and conducting clinical trials involving human subjects. She has been published and widely quoted on a variety of medical device and medical cybersecurity topics in: • AAMI Horizons • Journal of mHealth • Medical Products Outsourcing • Mass Device • ExecutiveGov.com • Fierce Medical DevicesShe has also participated in podium talks and panel discussions for: • Advamed • INCOSE • MD&M West • BioOhio • HIMSS Privacy and Security Forum. Ms. Masters participated in the AAMI Device Security Working group that created and published the first edition of AAMI TIR57: Principles for medical device security—Risk management. She currently serves as an outside advisor on the OhioHealth Learning Advisory Board. In addition, Ms. Masters holds a Regulatory Affairs Certification (RAC) and has a working knowledge of domestic and international regulatory requirements for medical devices.