Emily Koehler Email & Phone Number

Raleigh, North Carolina, United States

Raleigh, North Carolina, United States

Rsm, Ca

Project management of device algorithm updates for ENT generation 2 device via FDA filing/ device testing.Risk management file management/authoring for associated projects; Human Factors Assessment, HFA, HA, FMEA, DO, DI, etc.Research on clinical expansion of device indications use via surgeon consults, in-vivo lab testing, and applicable previous 510k filings.Authoring protocol and test methodology with relevant clinical data & research to acquire/identify new user needs in the field.Engineering liaison role for multiple OR cases for launch of Volant updated algorithm in 2019-2020; served as Engineering liaison in Houston, TX; Birmingham, AL.Department contact on Histology lab H&E training, protocols, and implementation for research purposes and GLP incorporation of lab.Direct involvement in Engineer I and Engineer technician hiring/talent acquisition for 2020-2021.

Rancho Santa Margarita, Ca

Managing script updates to current mechanical devices, facilitating project through design control processes, preparing FDA 510k submission documentation, troubleshooting script architecture with R&D on tissue properties, managing the implementation of a Histology lab on-site

Millbrook Ny, Buffalo Ny, Anaheim Ca

Tutoring mainly for High School-level students in preparation for Geometry, Algebra, Algebra II Trigonometry, and Pre-Calc Regents and common-core evaluations. Students are encouraged to problem solve and emphasize to use key concepts learned in class to attack problems and get a better understanding of course material.

Grand Island, Ny

Communicated with contractors and senior engineers to design and collect data for the growth of production lines and capacity of drug output through small project assignments, gained knowledge of cGMPs and SOPs that provided for the framework of operations. Additionally led HVAC installation project to re-route clean air to cleanrooms, assisted in management of heat exchanger replacement project for TS3, performed facility checks to ensure sterility in production zones.

Research within Biomedical Engineering department on FES- functional electrical stimulation developments and effects relating to stroke & SCO patients, as well as a method for muscular therapy.

University At Buffalo

Served as organizational lead of over ten committees within the fraternity, including professional development, academic, community service, and fundraising. Set up multiple meetings to communicate ideas and create workshops/events for the fraternity to benefit from. Committee personnel, calendars, events, and budgets were all closely monitored and designed with my assistance.

Poughkeepsie, Ny

Attended IRB meetings, prepared IRB paperwork & protocol, actively worked on disaster medicine research, shadowed robotic surgeries, helped to prepare/attended clinical trial consents through VBMC, shadowed doctors in Trauma, Oncology & Neurology departments, assisted in creating new triage plan for 2017-2019 implementation. Published in Crisis Response Journal regarding disaster medicine/trauma technology.

Organize and manage professional development events for UB's engineering fraternity. These events include; resume building workshops, tours at engineering-related facilities, and guest speaker presentations from engineering companies.

Eboard member for organized fraternity of engineer majors. Handled paperwork, documents meetings, handles email correspondence with members in and out of the Mu Gamma chapter, organizes fraternity documentation.

Master Of Science - Ms, Engineering/Industrial Management

Bachelor'S Of Science, Biomedical Engineering, Senior

Activities and Societies: Theta Tau Professional Engineering Fraternity, Biomedical Engineering Society, UB Women's Club Soccer

Regents Diploma