Senior Electrical Engineer #124
Senior Electrical Engineer sought by Hologic, Inc. (Danbury, CT) Lead electrical dsgns for new medical device development. Up to 10% domestic travel to various Hologic offices & vendor locations.
Requires a Bachelor's degree in Electrical Engineering, Electronics Engineering, or related & 8 years of exp developing Class 2 & Class 3 medical device electrical & electronic products. 8 years of experience must include 8 years of experience with each of the following: Quality & Risk Management Process - ISO13485, ISO14971 & 21CFR Part 820 in developing medical devices; designing & testing medical device per international electrical standards related to medical devices incl IEC60601-1; applying electrical design techniques to design complex electromechanical products; Leading & performing root cause analysis to debug problems during development, verification & compliance; Leading teams of engineers & technicians to complete projects; & releasing Class 2 & Class 3 medical device into US & European market with required approval incl 510K, PMA & CE approval.
ref. code 124.