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Medical device engineer

Company: Global Channel Management, Inc.
Location: Elizabeth
Posted on: September 13, 2019

Job Description:

Medical device engineer needs 5+ years experience in Medical Device Quality Systems and/or Quality Assurance Medical device engineer requires: Bachelors Degree is required, with preference for natural sciences or engineering First-hand experience with implementation of EU MDR requirements Strong technical writing skills Experience with Documentation Control and Change Control Electro-mechanical, analog & digital debug and trouble-shooting, Test fixture project management, test automation, automated test equipment and software using C #, Visual Basic, Visual C++, Perl scripting. Powershell, Labview, LabWindows and/or TestStand Medical device engineer duties: medical device technical files will be reviewed to ensure use of prohibited hazardous substances are in accordance with the limits set forth in the General Product Safety Requirements (Annex I), and records will be created as necessary to fulfill the requirements of the various Annexes. provide hands-on expertise to revise and document the Quality Management System, Clinical, Post-Market Surveillance, and Supplier Management processes as necessary for compliance with the European Union Medical Device Regulations (EU MDR).

Keywords: Global Channel Management, Inc., Elizabeth , Medical device engineer, Engineering , Elizabeth, New Jersey

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