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Mechanical Engineer III

2 months ago

Lawrence, United States Fresenius Medical Care Full time
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 complex electro-mechanical components and assemblies for next generation home dialysis instruments. Components include pumps, motors, pneumatics, couplings, sheet metal housings, and PCBA mounting/cabling
  • Analysis of mechanical systems, including geometric 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 designs and/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- related risks are identified and appropriately mitigated
  • Work with Quality Assurance to maintain documentation in 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.

EO/AA Employer: Minorities/Females/Veterans/Disability/Sexual Orientation/Gender Identity

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

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