Design Quality Engineer - Plano - Cygnus Professionals Inc.

    Cygnus Professionals Inc.
    Cygnus Professionals Inc. Plano

    9 hours ago

    Technology / Internet
    Description
    • 6+ years of Medical devices - Design Quality experience for the projects related to Design Change, Clinical and New Product Development.
    • Good experience in Medical devices regulations – ISO13485, FDA & EU MDR regulations
    • Experience in compiling Design history files & Technical file submission for 510k & CE mark
    • Own Risk Management files – Risk management plan, Hazard Analysis, DFMEA, UFMEA, Risk Management report
    • Work with cross functional teams to execute and/or support various areas of Design Control processes, such as Design Input requirements, Design Outputs, Design Verification and Design Validation.
    • Review & approve all the design history files with cross functional teams (including software deliverables)
    • Support product development equipment qualification activities, test method development and validation activities.
    • Strong in Medical devices technical documentation
    • Excellent verbal, written, and interpersonal skills with ability to effectively communicate at multiple levels in the organization.
    • Strong analytical/problem solving, critical thinking, and presentation skills.

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