Presenter

Melissa Lemke is a Senior Principal Human Factors Engineer at Kymanox with experience in managing and applying human factors during the design and development of combination products and medical devices. Melissa has extensive consulting experience and technical knowledge of human factors regulatory requirements and strategies, preliminary analyses, formative evaluations, and validation studies. Melissa brings over nineteen years of experience in human factors applied to medical product design and development, with subject matter expertise in regulatory human factors engineering, use risk analyses, and study design and conduct. During her career, Melissa has authored numerous book chapters and peer-reviewed journal articles as well as technical reports and training products. She is a part-time Instructor at the University of Wisconsin at Milwaukee for Principles of Human Factors and Usability as well as an AAMI faculty member for Human Factors for Medical Devices. Melissa graduated from Marquette University with a MS in Biomedical Engineering and from North Carolina State University with a BS in Biomedical Engineering. She completed human factors coursework at both universities and her thesis focused on the assessment of usability and accessibility of medical devices for people with disabilities with the Rehabilitation Engineering Research Center on Accessible Medical Instrumentation at Marquette University.