The Manufacturing Engineer Co-op will gain valuable knowledge pertaining to policies, practices, and processes associated with the production of Medical Devices through completion of web-based and instructor-led training. This role offers hands-on experience with primary machining processes including CNC milling, CNC turning, and forming of titanium, stainless steel, and polymer implants. The co-op will also gain experience with the design of tooling, work holding, and job aids, and will be exposed to and participate in Quality and Compliance related activities, including Non-conformance investigation and Corrective and Preventative Action (CAPA). Additionally, the co-op will assist in failure mode analysis, scrap analysis, and trending, and gain exposure to concepts of GMP/GXP as well as an introduction to FDA, ISO, Safety, and Environmental regulations. The role involves acting as a team member supporting capital investment projects and transformations, conducting research, data collection, and technical report generation, performing financial analysis, generating business cases, and conducting presentations. The co-op will also perform CAD modeling and drafting activities for 3D printed and machined manufacturing tools/fixturing, equipment layouts, and process documentation, and support the development of new processes and equipment associated with product launches. Coordination and support of equipment and process validation lifecycle elements such as computer system validation, safety risk assessment, installation qualification, process risk assessment, operation qualification, and performance qualification are also key responsibilities. The co-op will author equipment and process standard operating procedures, test protocols, and technical report documents, perform data collection and analysis utilizing statistical methods and software packages such as MS Excel and Minitab, and participate on cross-functional teams focusing on the improvement of existing processes. Support for cycle time analysis, process/value stream mapping, and capacity analysis on production processes to optimize and/or introduce new equipment, as well as assistance with testing and analysis utilizing Lean/6 Sigma tools and techniques, and completion of Kaizen implementation for ideas submitted for improvements are expected. The co-op will communicate with internal and external suppliers on various projects and initiatives, and participate in plant and product familiarization through a combination of independent research, online training, and “Go-See” activities. Finally, the co-op will participate in shadowing of various roles including Manufacturing Engineers, Quality Engineers, Engineering Technicians, and Production Operators, and will also “Go-See” groups including Chemical Finishing, Packaging, QA Inspection, Drafting, Document Control, Safety, Maintenance, Tool Room, Gage Calibration, and Shipping/Receiving.
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Job Type
Full-time
Career Level
Intern
Education Level
Associate degree