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Jr. Manufacturing Process Engineer - Canada  

PerkinElmer (company)


Posted on : 21 April 2017

Project Description

  •  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 to shared/mixed manufacturing with Shelton, Connecticut and Taicang China facilities.

  • 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.

  • 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).   

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