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.