|Reference # : ||19-01843
||Title : ||Manufacturing Engineer/Validation Engineer|
Pleasanton, CA; Plymouth, MA; Westford, MA, CA
|Position Type : ||Contract|
|Experience Level : ||
||Start Date : ||01/10/2019
| Description |
· 5 to 6 years of Process Validation (IQ, OQ & PQ) and test method validation experience, especially cardiovascular products or any electro-mechanical products
· Experience in process characterization, Gage R&R studies.
· Knowledge in Statistical data analysis & Minitab.
· Experience in working with Medical devices manufacturing ? ISO 13485, 21 CFR 820 & Med dev.
· Knowledge in Risk Management per ISO 14971 ? PFMEA.
· Knowledge in the change control process in PMS systems
· Creation of Routers & BOM in SAP
· Knowledge in fixture design