**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.**