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.