Project Engineer Sr

Our client is currently seeking a Project Engineer Sr in Allendale, NJ. This role will require validation/manufacturing experience as this is a Process Project Engineering role. This is a 1+ year contract opportunity and the hiring manager is looking to set up interviews. Please submit all qualified resumes to dglodek@judge.com. The Senior Project Engineer will have the following responsibilities: Support the process development and introduction of new orthopedic products. Work extensively with Operations, Manufacturing, Product Development and Quality 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 quality system to produce documentation such as process validations, equipment qualifications, dynamic control plans, inspection plans and standard operating procedures Operate within '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) 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 suppliers to ensure they understand and comply with our Quality and NPDP system requirements, particularly for Supplier Innovation role Qualifications & Requirements: 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 ID: 586946 Type: Contract Salary: Open

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