Kimberly Tetuan, MEM, RAC-Devices

Kimberly Tetuan, MEM, RAC-Devices has held a variety of roles in the medical device industry since 2005. From 2005-2011, they were a Lifeguard/Swim Coach/Supervisor at the YMCA, where they were responsible for the safety and well-being of members and guests in the pool area, daily operation of the pool, and developing and implementing swimming practices. In 2011, they held a Product Development Intern role at Terumo Cardiovascular Systems, where they analyzed International Standards utilizing the DOORS database, participated on Corrective Action/Preventative Action team, and authored protocol and executed experiments for the pressure drop of aortic and venous cannulae. From 2013-2019, they were an Associate Engineer and then Development Engineer at Invacare Corporation, where they led multifunctional teams to implement multiple engineering changes on the Complex Rehab product line, labeled all class 2 medical device products with a Unique Device Identifier (UDI), and created 510k and Design History File documentation required to launch a new power wheelchair to North American and European markets. Most recently, they have been the Regulatory Affairs Manager at Lumitex, Inc. since 2019.

Kimberly Tetuan obtained a Bachelor's degree in Bioengineering and Biomedical Engineering from The University of Toledo between 2008 and 2013. Kimberly then went on to obtain a Master's degree in Engineering Management from Ohio University between 2014 and 2017. In December 2019, Kimberly Tetuan obtained the Regulatory Affairs Certification Program (RAC-DEVICES) from REGULATORY AFFAIRS CERTIFICATION PROGRAM.