Design Quality Engineer - Medical Devices

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San Jose, CA
$125,000 - $150,000
Job Type
Direct Hire
Bachelor of Science
May 31, 2018
Job ID
Well established and highly regarded medical devices development incubator seeks a Design Quality Engineer to lead quality initiatives in the development of unique Class III medical devices.  This highly regarded life sciences incubator offers exceptional compensation and benefits.

  • Bachelor's degree in Engineering or related technical discipline with a preference for mechanical engineering, electrical engineering or chemical engineering
  • 7+ experience in a Quality Engineering role with a track record of accomplishment new product development
  • Strong working knowledge of Design Controls, Risk Management and manufacturing process controls 
  • Experience with electrical components (IEC-60601-1) and software (IEC 62304) and FDA guidance for software development.
  • Experience with FDA 21 CFR 820 and ISO Standards (ISO 13485 and ISO 14971) 
  • Experience with non-conformances, CAPA, complaint investigation
  • Experience using statistical methods and process/design excellence tools to establish test plan as well as evaluate test data and processes
  • Able to read detailed blueprints, with experience in CMM (Coordinate Measuring Machine), GD&T (Geometric Dimensioning and Tolerancing),
  • Experience conducting risk analysis activities (dFMEA, uFMEA, pFMEA) as required
  • Strong technical writing skills and ability to create technical protocols and reports as well as manufacturing / inspection procedures
  • Some background and knowledge in medical device software preferred
  • ASQ Certified Quality Engineering (CQE) desired
  • Experience with FDA 21CFR 210 & 211 desired