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 create, 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, 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