Product Development Engineer

1 month ago


Mahwah, United States Comrise Full time

Product Development Engineer- Medical Device Manufacturing Company

Long term contract- Healthcare and PTO benefits offered


  • Support the development and introduction of new orthopedic products. Work extensively with Product Development, Quality and Operations to take a product from design concept through production ramp up.
  • Participate in multifunctional teams, led by a Project Manager and be responsible for defined project deliverables
  • Support New Product Development logistics such as tracking part requirements, working with the manufacturing cells and Project Engineers to process development parts, coordinate shipments from and to suppliers, create and follow schedules for part requirements throughout the process development activities.
  • Manage Engineering Change Notices for new products from creation to final approval
  • Operate within Company’s quality system to produce documentation such as process validations, equipment qualifications, dynamic control plans, inspection plans and standard operating procedures
  • Operate within Company’s ‘New Product Development Process’ [NPDP], to build robust processes through involvement in ‘Design for Manufacturability’ and ‘Lean Manufacturing’ initiatives
  • Utilize Six Sigma process tools such as ‘Define, Measure, Analyze, Improve, Control’ (DMAIC), ‘Failure Modes & Effects Analysis’ (FMEA), ‘Design of Experiments’ (DOE), Gage Repeatability & Reproducibility’ (Gage R&R), ‘Statistical Process Control’ (SPC), capability analysis as required
  • Create and execute equipment validation protocols for Factory Acceptance Testing, Supplier Acceptance Testing, and Equipment Qualifications as required.
  • Create and execute Process Qualification protocols as required.


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