Andrea Dwyer is an Associate Research Director with Emergo by UL’s Human Factors Research & Design (HFR&D) team and has been with the team since 2010. A board-certified human factors professional, Andrea leads and oversees research activities required to meet regulators’ expectations for applying human factors engineering (HFE) during medical device development. She composes HFE project plans and helps medical device and pharmaceutical manufacturers develop key HFE documents for their design history files, including authoritative HFE reports and comprehensive use-related risk analyses. She frequently conducts workshops, speaks at industry events, and advises clients on how to implement HFE in the medical device development process. Andrea is co-author of Medical Device Use Error – Root Cause Analysis. She holds a B.S. in Human Factors and an M.S. in Engineering Management, both from Tufts University.Areas of expertise: • Applying human factors engineering to medical device development• Usability testing of medical devices• Root cause analysis of medical device use errors• Human factors engineering for combination products• Residual risk analysis• HFE report development• Managing human factors teams• Recruiting participants with rare medical conditions• Engineering management