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IVD Design Engineer

HCL America Inc.

This is a Contract position in Pima County, AZ posted September 16, 2020.

Systems Engineer Mechanical Engineer, 8 years of experience in Medical Device New Product Development, DHF Remediation Expertise in all phases of Systems Development in an IVD environment Able to understand system level interactions Knowledge experience on medical device design controls DHF remediation and MQMS process – ISO 13485 ISO 14971. Design and validate technical solutions to enhance product and process capability Good understanding on risk assessment Extensive experience in Design verification activity Able to do the change management change review process Demonstrated knowledge of sound design principles and practices Ability to read understanding, engineering drawings and Interpret the operationfunctions of the component Good understanding CAD tool, Solid works 2018 Extensive experience in problem solving through structured approach Works closely with external and internal design teams to understand and resolve product performance issues Excellent communications skills with ability to write technical and quality documents in a clear and structured manner, (procedures, verification plans , reports) Ability to work independently and be self-motivated