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Jr. Manufacturing Process Engineer Caledon Canada,  

Posted on : 21 April 2017

Project Description

Job Type : Full Time Career Level : Experienced (Non-Manager) Education : High School or GED Location : Bolton ON CA Job Description : JOB PURPOSE: Responsible for evaluating manufacturing processes, ensuring that we meet all relevant expectations for certification by ISO13485, (FDA) 21 CFR 820, CE-IVD, and CMDCAS regulations. This position will also support the transition from full manufacturing in Bolton to shared/mixed manufacturing with Shelton, Connecticut and Taicang China facilities. DUTIES AND RESPONSIBILITIES / ESSENTIAL FUNCTIONS: Help develop, evaluate, and improve manufacturing methods in compliance with FDA (21 CFR 820) and ISO 13485 requirements. Understand all processes in manufacturing (electronics, mechanical) and maximize efficiencies, quality and safety of operations. Identity quality and process enhancements for the manufacture of instruments. Confer with product development team to ensure manufacturability of new products introduced to manufacturing. Collaborate with product development team to design tooling and fixtures to support new products. Help to investigate various types of new jigs, fixtures, machinery and equipment for production. Work closely with production personnel to ensure consistent product flow. Work closely with multi-functional teams including product development and QA, to address on-going manufacturing issues, supplier quality, and field problems. Perform time studies and load standard rates into ERP system. Help to generate ECOs for revision control of product specific documents. Will help to ensure engineering data and assembly procedures are complete and accurate to ensure conformance to the following standards: ISO 13485 FDA CFR 821 (Medical Device Tracking) CE-IVD (Europe) CMDCAS (Canada) Help to facilitate the design transfer of subassembly manufacturing and integration knowledge to our supporting sites. Help to conduct manufacturing process FMEAs. Review and correction of Documentation (Procedures, Work Instructions, Forms).   Job Requirements : Education: Engineering degree and 2+ years’ experience in a manufacturing process engineering role. Skills: Knowledge in Electronics Vendor techniques and capabilities. Knowledge in Mechanical vendor techniques and capabilities. Working knowledge of lean manufacturing techniques. Experience working under an ISO 13485 registered company or FDA regulations. Experience with ERP systems such as SAP or Epicor. Proficiency with Microsoft Office (Word, Excel, PowerPoint). WORK ENVIRONMENT: Production Environment PHYSICAL REQUIREMENTS: Sitting, standing, walking, climbing stairs  


Bolton ON CA

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