Senior Manufacturing Engineer

Basic Qualifications:       
Masters’ degree in Mechanical, Industrial, Manufacturing Engineering or related engineering field and two (2) years of experience as a product or manufacturing engineer or related occupation OR Bachelor’s degree in Mechanical, Industrial, Manufacturing Engineering or related engineering field and five (5) years of experience as a product or manufacturing engineer or related occupation. Must possess at minimum 2 years’ experience in each of the following: Process validation including IQ/OQ/PQ for mechanical assembly devices, injection molding, extrusions, component evaluation/qualification and mechanical engineering; Lean Six Sigma methodologies, including GMP, VSM, DOE and statistical analysis; Process and Design FMEAs; ISO13485, ISO 14971, ISO 9001, 21 CFR 820, EU MDD, and EU MDR; Root cause analysis to include Cause/Effect, Fault-tree Analysis, 5S, Statistical Process Control, GR&R, Defect Analysis, and Process Capability studies; and PLM, ERP software, Minitab, Creo, AutoCAD, and Solidworks.