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Reference # : 19-01843 Title : Manufacturing Engineer/Validation Engineer
Location : Pleasanton, CA; Plymouth, MA; Westford, MA, CA
Position Type : Contract
Experience Level : Start Date : 01/10/2019  
Job 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