Manufacturing Engineer (Medical Device)

Company: Aspect Medical Systems is a global market leader in brain monitoring technology. To date, the companys technology has been used to assess over 14 million patients and has been the subject of over 2300 published articles and abstracts. The companys technology is installed in over 70 of US hospitals in the July 2005 US News and World Report ranking of Americas Best Hospitals and in 45 of all US operating rooms. The technology is available in more than 160 countries. The company is public, located in Newton, Mass., and won an award from Boston Business Journal as 1 of the top 20 Best Places to Work amongst mid sized employers with 300 companies participating.


Aspect was recently chosen as #14 in the Boston Globe Top 100 Companies in the Greater Boston area.Manufacturing Engineer (Medical Device)ResponsibilitiesDesign and improve performance of automated production/test equipment and processes. Design/execute experiments and perform other activities aimed at improving quality, throughput and efficiencies. Represent manufacturing in new product design and development. Assist with our transfer to a larger facility and with installation/validation of automated assembly equipment. Write validation plans and oversee process validations.Provide technical support and guidance to Sensor Production. Requirements: Bachelors Degree in Mechanical or Manufacturing Engineering or equivalent education and/or experience with 3-5 years of related experience in a high volume automated assembly environment. Thorough understanding of FDA Quality System Regulations and ISO Quality Systems Requirements Fixture design experience using CAD system(s) preferably Pro-E and /or AutoCAD Medical Device experience and/or Lean Manufacturing/Six Sigma tools, statistics and experimental design is preferable. ...

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