Background
Emily is a member of MCRA's usability engineering team. She specializes in usability testing strategies, development of usability engineering file (UEF), risk analysis, medical and regulatory writing, usability engineering process, design of usability study as well as usability study as part of a clinical study, and engineering review of labeling materials. Emily advises and designs usability studies for medical devices and combination products across all therapeutic areas.
Education
Emily received a Bachelor of Science degree from the Virginia Polytechnic Institute and State University, with a major in Mechanical Engineering and a minor in Biomedical Engineering.
Experience
Emily is an engineer with 5 years of experience in the medical device industry, with 3.5 years of experience in usability engineering and 1.5 years of experience in medical device quality assurance.
Prior to joining MCRA in 2025, Emily worked in engineering consulting, where she gained experience in medical device development with special focus on mechanical design and usability engineering. Emily has experience with 3D modeling and rapid prototyping of products, especially of home-use devices. Additionally, Emily has performed benchtop testing and verification and validation testing as part of her development work, including usability testing to demonstrate safe and effective use of the device. Through the support of multiple clients at different stages of the development process, Emily has drafted key design history file deliverables to document the design and all testing performed.
In addition to engineering consulting, Emily was a R&D Quality Assurance engineer for a medical device manufacturer who focused on complex catheter delivery systems. In her role as a quality engineer, Emily ensured compliance to internal processes as well as compliance to external regulations, namely ISO 13485 and 21 CFR Part 820. Emily has participated in both internal and external audits during her tenure in quality to support her clients through the regulatory approval process.
Based on her experience in both development and manufacturing settings, Emily can support clients from multiple perspectives.