• Engineer - sr

    Job Location(s) US-NJ-Mahwah
    Posted Date 3 weeks ago(4/5/2018 12:12 PM)
    Job ID
    2018-29125
    Category
    Engineering
    Position Type
    Contract (Full-Time)
    # of Openings
    1
  • Responsibilities

    • 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 new equipment installation activities with the facilities team to deliver the work on schedule and budget. 
    • Work closely with the project team to gather equipment installation requirements and act as the point of contact for the facilities team. 
    • eview bids from contractors to ensure project is on budget. 
    • Maintain equipment installation schedule by monitoring project progress; coordinating activities; resolving problems in collaboration with the facilities team and Project Manager. 
    • Act as a point of contact for the facilities team for the Customs, R&D Prototypes, Process Engineering, Advanced Operations, Advanced Technology, and Scorpio cell relocation activities. 
    • Work closely with the Continuous improvement team to develop the cell layout and process flow for the Triathlon Globalization Femur utilizing lean six sigma tools. 
    • Create documentation in Company’s validation system for Master Validation Plan, Process Qualification, Factory Acceptance Test, Site Acceptance Tests, Equipment Qualification, and Measuring System Analysis (GR&R) 
    • 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 
    • Provide input to Capital Equipment Requests (CERs) 
    • Create and execute Process Qualification protocols as required. 

    Qualifications

    • 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. 
    • 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.

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