Regulatory consulting services at competitive rates in the medical device and combination product industries

Denise Wagner

 
 

Denise Wagner, MS

principal human factors & systems engineering consultant

Denise is a consultant with over 30 years of experience in medical device product development, academia and aerospace. She has subject matter expertise in usability engineering, systems engineering, design control and risk analysis in both the medical device and aerospace industries. Denise has a passion for ensuring products and systems are safe and effective. She has served as a member of both the AAMI Human Factors Engineering Committee and the AAMI Foundation for the Safe Use of Complex Medical Technology. Before becoming an independent consultant Denise was the Sr. Director of Human Factors Engineering at Agilis Consulting Group. Prior to that she lead the Orthopedic Robotics Systems Engineering Team for Johnson and Johnson’s Orthopedic Company, DePuy Synthes. Denise also held several positions at Zimmer (now Zimmer Biomet) including serving as the Associate Director of the New Product Development Process for Zimmer’s Reconstruction Division. She began her engineering career at NASA’s Johnson Space Center where she supported multiple space shuttle missions and completed her graduate research on time-delayed tele manipulation for the space station. Denise has also taught numerous courses in the Engineering and Business schools at Trine University.