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Rapidly growing medical devices company is seeking a Design Assurance Engineer to work as a member of the design team developing an electromechanical cardiac mapping platform.  This well-funded privately held company is positioned to go public next year.   

Requirements:
 

  • Bachelor’s degree in engineering or related technical discipline with a preference for mechanical engineering, electrical engineering or chemical engineering
  • 5+ years’ experience in a quality engineering with a track record of accomplishment in new product development
  • Quality experience with cardiovascular products
  • Experience with electromechanical systems preferred
  • Strong working knowledge of Design Controls, Risk Management, V&V and manufacturing process controls 
  • Experience with FDA 21 CFR 820 and ISO Standards (ISO 13485 and ISO 14971) 
  • 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
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