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Lawrence

    Mechanical Engineer III - Lawrence, United States - FRESENIUS MEDICAL CENTER

    FRESENIUS MEDICAL CENTER
    FRESENIUS MEDICAL CENTER Lawrence, United States

    3 days ago

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    Description

    Position Summary:

    Take a key role in developing and improving NxStage's products. This individual will apply sound engineering principles to the development of new products and will be involved in all parts of a product's life, from feasibility evaluation for new features and products to improving the quality, performance, and cost of dialysis therapy. You will be part of a team with responsibility for supporting a specific product line. Close collaboration with manufacturing, quality, regulatory, and product management counterparts is key to quickly responding to issues, completing projects, and launching new products.

    Responsibilities:

    • Collaborate with systems, electrical, disposable, and software engineers to create, test, and improve complexelectro-mechanical components and assemblies for next generation home dialysis instruments. Components include pumps, motors, pneumatics, couplings, sheet metal housings, andPCBA mounting/cabling
    • Analysis of mechanical systems, includinggeometric tolerancing and Finite Element Analysis for structural, fatigue, thermal, vibration, and acoustics
    • Develop manufacturing drawings in accordance with applicable standards
    • Construct and test / oversee technicians in constructing and testing of prototype systems
    • Troubleshoot new designsand/or develop reliability improvements for existing designs
    • Improve designs for reliability, manufacturability, and performance
    • Participate in the development of product specifications and requirements documents
    • Support and/or conduct Risk Analysis activities, including Fault Tree Analysis (FTA), Operator Misuse Analysis (OMA), and Failure Mode and Effects Analysis (FMEA) to ensure design- and process- relatedrisks are identified and appropriately mitigated
    • Work with Quality Assurance to maintain documentationin accordance with the approved internal Quality System that meets applicable GMP, QSR, ISO13485, and other requirements
    • Support the design, development, testing, and/or use of complex automated and semi-automated assembly and test equipment
    • Manage vendors to insure rapid delivery of prototype components

    Skills :

    • Proficient in Solidworks 3D modeling, standard analysis tools and methodologies, mechanical detailing, geometric tolerance analysis, and documentation is preferred
    • Strong understanding of medical device development processes
    • Able to communicate effectively, both verbally and in writing
    • Strong diagnostic & problem-solving skills desired, including troubleshooting and root cause analysis
    • Experience maintaining the confidentiality of sensitive information
    • Experience with design of experiments
    • Familiarity with fabrication methods such as machining, molding, sheet metal, and casting processes
    • Demonstrated aptitude for practical application of mechanical, pneumatic, and electrical to system design. Design for EMI/ESD.

    Minimum Requirements:

    • BS in Mechanical Engineering, MSME is a plus
    • 5+ years of experience in product design, development, and/or testing of complex electro-mechanical products
    • Prior medical device experience strongly preferred

    Fresenius Medical Care North America maintains a drug-free workplace in accordance with applicable federal and state laws.

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