Erin Keegan (2014 Alumna)

“The CMTI program provided me with explicit regulatory knowledge through the joint IP/FDA course but also equipped me with tools throughout the entire program that I use every day at the FDA. … I met my FDA contact through this same FDA/IP course which is what has landed me a job that I love!” 

ErinKeegan“I’m a recent grad of the CMTI Master’s program and also attended the University of Rochester for my undergrad in Biomedical Engineering. I’m currently working at the Food and Drug Administration in the Office of Device Evaluation for the Division of Neurological and Physical Medicine Devices (DNPMD). My specific Branch within this division is the Neurostimulation Devices Branch (NSDB) and my official job title is “Lead Reviewer”. The CMTI program provides knowledge about the entire device development process through topics such as business/entrepreneurship, IP, regulaltory, human factors, manufacturing processes, standards recognition, QSR, testing plans (with specifications and acceptance criteria!!), as well as extended knowledge in many different engineering fields. These topics have prepared me for interactions with sponsors and the review of the data in the submissions. This has been especially helpful as an EFS rep where I advise sponsors very early on in their device development process. CMTI enables me to ‘take a walk in their shoes’ because through the program we have been exposed to that early stage developement of a device. Additionally, skills such as public speaking, facilitating interactions between people with many different specialities, and problem finding/defining are skills that I use every day. Finally, as a Senior Design TA I have directly applicable experience in reviewing device development documents which isn’t so different than what I do here now.” – Erin Keegan, Biomedical Engineer, B.S., M.S.

Comments are closed