Project Engineer - sr

4 days ago
Job ID
Position Type
Contract (Full-Time)
# of Openings


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 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) 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 Company Orthopedics 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, please see below: 


• 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 


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