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/cablingAnalysis of mechanical systems, includinggeometric tolerancing and Finite Element Analysis for structural, fatigue, thermal, vibration, and acousticsDevelop manufacturing drawings in accordance with applicable standardsConstruct and test / oversee technicians in constructing and testing of prototype systemsTroubleshoot new designsand/or develop reliability improvements for existing designsImprove designs for reliability, manufacturability, and performanceParticipate in the development of product specifications and requirements documentsSupport 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 mitigatedWork with Quality Assurance to maintain documentationin accordance with the approved internal Quality System that meets applicable GMP, QSR, ISO13485, and other requirementsSupport the design, development, testing, and/or use of complex automated and semi-automated assembly and test equipmentManage vendors to insure rapid delivery of prototype componentsSkills:Proficient in Solidworks 3D modeling, standard analysis tools and methodologies, mechanical detailing, geometric tolerance analysis, and documentation is preferredStrong understanding of medical device development processesAble to communicate effectively, both verbally and in writingStrong diagnostic & problem-solving skills desired, including troubleshooting and root cause analysisExperience maintaining the confidentiality of sensitive informationExperience with design of experimentsFamiliarity with fabrication methods such as machining, molding, sheet metal, and casting processesDemonstrated 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 plus5+ years of experience in product design, development, and/or testing of complex electro-mechanical productsPrior medical device experience strongly preferredFresenius Medical Care North America maintains a drug-free workplace in accordance with applicable federal and state laws.