Project Engineer - Medical Device

• 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.

Qualifications and Work Experience Required:

• 2+ years of engineering experience in the Medical Device, or similar, quality regulated industries.
• Demonstrated understanding of manufacturing processes, e.g. casting, forging, CNC machining, CMM inspection, etc.
• Strong organizational skills, attention to detail, time management and planning skills.
• Ability to work well with others within a functional team environment.
• Demonstrated familiarity with theory and practical application of ‘Geometric Dimensioning & Tolerancing’ (GD&T)
• Demonstrated familiarity with statistical analysis using Minitab, QC calc, MS Excel.
• Demonstrated experience with a parametric CAD design package, with a strong preference for ProE. Should be capable of developing 2D drawings, manipulating 3D product models and modeling moderately complex fixtures and gages.
• Demonstrated proficiency in Microsoft Outlook, Microsoft Project, Microsoft Visio and Microsoft Office applications.
• Demonstrated interpersonal, communication and presentation skills. Must be comfortable presenting at department level meetings
• Demonstrated experience dealing with suppliers and resolving supplier issues, particularly for Supplier Innovation role
• Must be challenged by a team-based environment which places a high degree of emphasis on accountability for customer satisfaction, cost reduction and quality/GMP compliance Education and Special Training Required: Bachelors degree in a science, preferably Engineering