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
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 compnay'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) and ‘Statistical Process Control’ (SPC) as required
Provide input to Capital Equipment Requests (CERs)
Project Engineers in New Product Innovation will also:
Program CNC, robotics and other manufacturing equipment to produce high quality, repeatable output in a cost effective manner
Develop fixturing, work holding and gaging solutions to optimize the manufacturing process
Project Engineers in Supplier Innovation will also:
Work with compnay's suppliers to ensure they understand and comply with our Quality and NPDP system requirements, particularly for Supplier Innovation role
Bachelor’s degree in a science, preferably Mechanical or Biomedical Engineering, Without a Bachelor’s degree may be considered with related work experience.
3-5 years of engineering experience in the Medical Device, or similar, quality regulated industries
Demonstrated fundamental understanding of manufacturing processes, e.g. casting, forging, CNC machining, coating, etc.
Demonstrated familiarity with theory and practical application of ‘Geometric Dimensioning & Tolerancing’ (GD&T)
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