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Engineer IV
Ref No.: 18-13130
Location: Lexington, Massachusetts
Start Date / End Date: 09/04/2018 to 09/03/2019
The Design Quality Engineer will provide technical quality leadership and support for Client’s medical device and combination product development efforts throughout clinical development, product registration, and commercialization. This DQE will support class 2 electromechanical and reconstitution devices, and other drug delivery devices as required. This DQE team member will work collaboratively with internal and external partners, on efforts such as design inputs, quality planning, risk management, design verification and validation testing, design transfer, and design changes. This DQE team member will ensure Client develops medical devices and combination products in accordance with FDA 21 CFR requirements and international standards (e.g., ISO, AAMI, ANSI).