• Project Engineer

    Job Location(s) US-NJ-Allendale
    Posted Date 3 weeks ago(10/2/2018 9:05 AM)
    Job ID
    2018-29928
    Category
    Engineering
    Position Type
    Contract (Full-Time)
    # of Openings
    1
  • Overview

    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

    Responsibilities

    • 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 client's quality system to produce documentation such as process validations, equipment qualifications, dynamic control plans, inspection plans and standard operating procedures
    • Operate within client’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 client's Orthopedics suppliers to ensure they understand and comply with our Quality and NPDP system requirements, particularly for Supplier Innovation role

    Qualifications

    • 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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