Mechanical Engineer III
Lawrence, Massachusetts
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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