Sr. Test Engineer
CurrentInsulet is an innovative medical device company dedicated to making the lives of people with diabetes and other conditions easier through the use of its Omnipod product platform. The Omnipod Insulin Management System provides a unique alternative to traditional insulin delivery methods. With its simple, wearable design, the disposable Pod provides up to three days of non-stop insulin delivery, without the need to see or handle a needle.• Setting the requirements for, specifying, designing, developing and implementing Medical Device Test Systems that include software and hardware.• Responsible for developing new test systems, technologies and processes to support high volume manufacturing of new and existing medical device Products.• Work with outside vendors to develop, install and validate test systems and manufacturing systems.• Participate on interdisciplinary teams to identify scope for required manufacturing test systems• Perform Systems Engineering Support Test System Design & Validation with thorough documentation of User Requirements Specifications, Functional design specifications, IQ, OQ, FAT, SAT and PQ efforts. • Determine test system requirements in accordance with FDA Regulations using: System Hazard Analysis, DFMEA and PFMEA.