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Engineer IV
Ref No.: 18-28505
Location: Lexington, Massachusetts
The Design Quality Engineer will provide technical quality leadership and support for Cleint'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 Cleint develops medical devices and combination products in accordance with FDA 21 CFR requirements and international standards (e.g., ISO, AAMI, ANSI).