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Posted May 13

Sr. Mechanical Engineer - Disposables

NxStage
Lawrence,MA

Requisition Number 17-0070 Post Date 4/4/2017 Title Sr. Mechanical Engineer - Disposables City Lawrence State MA Description
Sr. Mechanical Engineer - Disposables

Position Summary:
This individual will apply sound engineering principles to the development of new products at NxStage Medical Inc.

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, ISO, 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 tolerancing, and documentation
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 strongly preferred
5+ years experience in product design, development, and/or testing of complex electro-mechanical products
Prior medical device experience strongly preferred


















Requirements BS in Mechanical Engineering, MSME strongly preferred
5+ years experience in product design, development, and/or testing of complex electro-mechanical products
Prior medical device experience strongly preferred

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