Engineer, Disposables Manufacturing

TO APPLY FOR THIS POSITION, PLEASE VISIT THE CAREERS PAGE OF WWW.NXSTAGE.COM

 

NxStage Medical is a medical device company in Lawrence, MA that develops, manufactures and markets innovative systems for the treatment of end-stage renal disease and acute kidney failure.  NxStage?s primary product, the NxStage System One, is a small, portable, easy-to-use hemodialysis system designed to provide physicians and patients improved flexibility in how hemodialysis therapy is prescribed and delivered.  Given its design, the System One is particularly well-suited for home hemodialysis and more frequent, or ?daily? dialysis, which clinical literature suggests provides patients better clinical outcomes and improved quality of life.  The System One is specifically cleared by the US FDA for home hemodialysis as well as hospital and clinical-based dialysis.  We believe the largest market opportunity for our product is the home hemodialysis market for end-stage renal disease.  Come join us during this exciting time in our growth as a company!

 



SUMMARY: 

 



Support manufacturing engineering activities related to the manufacture of NxSTAGE Medicals disposable products.



 

SPECIFIC DUTIES: 

 

 

 

?  Participate in the development and implementation of manufacturing cells, including production line lay-out, fixture development, process improvement, mistake-proof fixturing, etc., required for the production of NxSTAGE Medicals disposable products.

?  Ensure all equipment and tooling are properly documented and under calibration and preventative maintenance control as required.

?  Troubleshoot and resolve manufacturing, quality, and supplier issues.

?  Develop and implement manufacturing procedures as required to produce NxSTAGE Medicals various disposable products.

?  Lead required process IQ, OQ, PQ elements of process validations including product and packaging ship testing and shelf life testing.

?  Lead FMEA activities to ensure process shortcomings are identified and appropriately addressed.

?  Lead projects to improve product reliability/quality, reduce assembly cycle time, and reduce costs.

?  Work with Research and Development and Quality Assurance to ensure NxSTAGE Medicals products are designed taking into consideration ease of manufacture and that product will adhere to performance, cost and quality requirements.

?  Investigate and report on customer complaints related to disposables products.

?  Serve as primary technical contact with component and sub-assembly vendors, addressing capacity issues and leading quality related projects.

?  Assist in assembly of various NxSTAGE Medical disposable products required to support bench test, clinical and limited sales and marketing units.

?  Train production personnel according to relevant SOPs as needed.

?  Perform disposable product functional testing as required.



REQUIREMENTS: 

 

 

?  B.S. in Engineering is required

?  5+ years experience in manufacturing engineering support and /or process development.

?  Experience in process and product development of medical devices is preferred.

?  Technical problem solving.

?  Working knowledge of design of experiments and other statistical tools.

?  Working knowledge Process Validation.

?  Working knowledge of ISO/QSR GMP requirements.

?  Knowledge of plastics forming (such as injection molding and extrusion), plastics joining (such as RF sealing, ultrasonic welding, heat sealing and solvent bonding) and plastic part design preferred.

 

LOCAL CANDIDATES ONLY, PLEASE