Jr. Manufacturing Process Engineer - Canada
- 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.
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 :
- 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).
Sitting, standing, walking, climbing stairs