Process Engineer

New Jersey

About our Client

30+ year established medical molder offering end-to-end solutions from design/development-sterilization/packaging with over 20 locations worldwide and 450+ molding machines.

  • 33 presses (40-300) ton
  • Class I, II, III medical devices
  • Class 8 cleanrooms
  • Multi-shot, insert & over-molding

Summary & Responsibilities

This position is responsible for providing sustaining engineering support for all existing processes and production with hands-on problem-solving techniques. This position will also provide major input into the design, development, and implementation of processes for new products and processes.  
  • Follow Good Manufacturing Practices (GMP's), policies and Standard Operating Procedures (SOP's) to ensure that FDA regulations are met
  • Focus on daily customer and process related issues to improve quality, on-time delivery and process efficiencies
  • Plan, lead, execute and complete projects to improve productivity and quality through proper investigation and data driven six sigma principals
  • Identify optimal conditions by evaluating factors such as material temperature, flow rate, pressure, and cooling rate during molding process
  • Develop and design engineered plastic parts, insert molded parts and assemblies
  • Analyze mold flow, part advisor analysis, finite element analysis, and stress/fatigue analysis
  • Support and develop validation protocols and reports (IQ/OQ/PQ)
  • Develop process documentation and training materials for new processes, materials, and equipment, including drawings, protocols, completion reports and specifications
  • Supervise Process Engineers, Process Technicians and Mold Set Up Technicians, set priorities for the day, troubleshoot and manage any personnel or mold issues

Requirements

  • Bachelor's Degree in Engineering; preferably in plastics engineering
  • 7 years of experience working as a process engineer with previous experience in medical devices
  • Experience with Scientific Injection Molding Principles in a related manufacturing environment
  • Experience with automation, robotics, PLCs and inspection systems
  • Familiarity with statistical problem solving and six sigma techniques.