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Medical Device Engineer III

Company: Oxford Global Resources
Location: Santa Clara
Posted on: November 21, 2020

Job Description:

Job Title Medical Device Engineer - III Location Mountain View, CA Length of Assignment 3 - 6 Months Start Date 120720 Job Description Responsibilities bull Establish and maintain design history file documentation for development projects (design and development plan, requirements specifications, device master record, IOV matrix, verification and validation summary reports, etc.) bull Establish and maintain risk management documentation (risk management plan, hazards analyses, failure mode and effects analyses) for development projects in accordance with ISO 14971 bull Coordinate product testing with vendors (e.g., mechanical shock and vibration, environmental conditioning, ISTA 3A, battery tests, IP22, etc.), including protocol development, sample coordination and writing test reports. bull Review deliverables from vendors, such as technical drawings, and technical reports. bull Generate and maintain technical specifications for product components bull Coordinate activities required to get parts suppliers added to ASL bull Generate technical protocols and reports bull Develop validation master plans, IQOQPQ protocols and reports for test fixtures and manufacturing equipment. Skills Required bull Excellent mechanical aptitude and good attention to details bull Experience designing and troubleshooting electronic and mechanical systems bull Experience with CAD software (SolidWorks) including preparation of engineering drawings using GDT preferred bull Experience in designing injection molded parts preferred. bull Experience programming in LabVIEW a plus. bull Well versed in FDA regulations for medical devices and products including Design Controls 21 CFR 820 and MDR bull Experience working in compliance with GMP regulations Education and Experience bull Bachelorrsquos or higher-level STEM degree, Physics or related field, or demonstrated equivalent experience bull 5 yearsrsquo product development experience in medical device

Keywords: Oxford Global Resources, Santa Clara , Medical Device Engineer III, Other , Santa Clara, California

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