Job Title: Senior Mechanical Engineer

The following represents some of the main responsibilities of the above position. This list is not in any order of importance and should not be considered an exhaustive list of possible duties of the position. NxStage Medical, Inc. maintains the right to modify this list at any time.

Summary

Support the Research and Development activities related to NxStage's embedded electro-mechanical devices.

Specific Duties:

• Lead equipment electro-mechanical design and development activities .
• Lead design verification and validation activities related to NxSTAGE equipment to meet design control procedures.
• Lead the development of assembly and test equipment and tooling required for the production of NxSTAGE Medical's equipment products. Ensure all equipment and tooling are properly documented and under calibration and preventative maintenance control as required at either NxSTAGE or its contract manufacturers.
• Participate in Risk Management activities to ensure design and process shortcomings are identified and appropriately addressed.
• Ensure NxSTAGE Medical's products are designed taking into consideration ease of manufacture and that product will adhere to performance, cost and quality requirements.
• Work with Quality Assurance to maintain an approved internal Quality System that meets the requirements of cGMPs, QSR and ISO 9001.
• Oversee production of equipment at contract manufacturers including ensuring operators are properly trained, production schedule is adhered to, production paperwork is accurate and working with production personnel in identifying areas for improvement.

Requirements:

• B.S. in Mechanical or Industrial Engineering is required.
• 10+ years experience in electro-mechanical product design, transition to manufacturing, manufacturing engineering support and /or process development.
• Experience in product and process development of medical devices is preferred.
• Experience with CAD/CAM and rapid prototyping process.
• Experience with molding and casting processes.
• Experience with system design, electronics and software integration.
• Working knowledge of design of experiments is preferred.
• Working knowledge of GMPs and QSR.
• Project leadership for development tasks.

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