Mechanical Engineer II

• Jun 2010 - Present

- Successfully led development of Class II Neural Engineering medical devices from concept development to design transfer with complete documentation to FDA requirements.- Actively involved in research and product development of various Class II medical products of other medical device companies.- Developed and conducted validation testing to support new product design and/or changes.- Conducted the documentation process at various phases of product development which frequently involved writing design specifications, test protocols, test reports, FMEAs etc.- Performed Design of Experiments, Finite Element Analysis, tolerance stack-up analysis, design layouts and proof of concept development with complete documentation.- Interfaced closely with manufacturing, quality control and other departments to resolve design concerns.

Design Engineer

• Jun 2009 - Jun 2010

- Provided proof of concept and modeled the development of high density, high precision systems to interface implantable neural engineering devices in brain.- Designed and conducted various test protocols and successfully validated sterilization, accelerated aging, and other mechanical tests on various animal and human products.- Conceptualized designs on various products for marketing/management to make project critical decisions.- Documented various assembly procedures, BOMs, Device Master Records and Device History Files.- Conferred with management, production, and sales to determine engineering feasibility.

Program Analyst

• Sep 2006 - Dec 2007