Mechanical Engineer III

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 creat e , 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, ISO 13485 , and other requirements
• S upport 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 & proble m- 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 electr o-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.