Process Engineer

SW Indiana

About our Client

60-year established, industry-leading electronics manufacturer with 10 facilities across the globe. They provide end-to-end engineering, design & manufacturing solutions for the automotive, industrial, medical, and public safety markets. This particular facility focuses on injection molded components for the medical device industry. They maintain ISO (9001, 13485, 14001) & IATF 16949 quality standards and are FDA registered.

Summary & Responsibilities

The mission of the Injection Mold Process Engineer is to develop, implement, and support injection molding processes as well as to verify and drive improvements while meeting goals of quality, cost, and delivery for our customers. This position reports to the Process Engineering Team Lead within the Operations department of a rapidly growing Medical Device contract manufacturer focused on surgical equipment, drug delivery devices, and disposables.    
  • Develop best practices to identify, study and deploy advanced molding/tooling technologies intended to drive lower costs, better quality, and faster product delivery through coordination with other technical resources
  • Responsible for the development of injection molding processes
  • Creating detailed manufacturing work instructions, set-up/change over instructions, control plans, and testing procedures in support of FDA requirements
  • Support continuous improvement by performing product/process analysis for quality improvements, cost reductions, and improved efficiency
  • Assist with development of new tooling and maintenance of existing tooling
  • Coordinate validation efforts with project managers, tool manufacturers and customers
  • Performs complex troubleshooting; repairs, modifies and maintains systems and/or equipment

Requirements

  • BS in Engineering or related field (preferred)
  • 2-5 years’ experience in plastic injection processing
  • Experience in Medical Device manufacturing (preferred)
  • Ability to Maintain general knowledge of the certification and regulatory requirements contained in ISO-13485, and FDA CFR/GMP Medical Device Regulation
  • Strong knowledge of scientific molding (RJG Master Molder preferred)
  • Experience with establishing D2 or D3 molding processes
  • Must be confident but approachable with a good sense of humor!