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    Business Process Analyst II - Fort Worth, United States - Aequor

    Aequor
    Aequor Fort Worth, United States

    2 weeks ago

    Default job background
    Upper Management / Consulting
    Description

    Job Title: Business Process Analyst II

    Duration: 9 Months

    Location: Fort Worth, TX

    Job Description:


    • Author Risk Management documentation for Class II & III Medical devices in compliance with ISO 14971 & EUMDR


    • Lead the development of Design History Files for class II & III Medical Devices in compliance with ISO 13485, EUMDR, MDSAP, and other standards/regulations relevant to medical Device Design & Development


    • Author Critical Design History File Documents, and lead cross-functional discussions to ensure alignment through the entire Design & Development Team


    • Serve as the representative for Design Control Team at cross-functional core team meetings


    • Lead design reviews, assign and review action items or delegate these tasks.

    Job Purpose ():


    • Works with wide latitude for unreviewed action or decision and represents the corporate direction in science and technology. Key functional expert who manages, direct and coordinates the activities of a specific area.


    • Strategic and/or management interface.


    • Supports engineering or scientific decision making by providing advice and recommendations to global project teams. Develop concepts and propose approach, to address identified ophthalmic medical device/science/technology needs.


    • Originate and apply complex concepts and propose new and unique approaches, methods, procedures and designs with regular use of creativity and originality to research and/or development.

    Ideal Background:


    • At a Minimum: Bachelor's + 7 years relevant experience, MS + 4 years relevant experience, PhD + 3 years relevant experience


    • Project management expertise with proven results in multiple areas.


    • Possess significant leadership skills to effect change.


    • Has proven ability to develop/implement advanced processes, techniques related to product development and/or critical systems.


    • Proven leadership track record of results.


    • Capability to motivate complex teams cross-functionally; directs strategic and business goals.


    • Expert knowledge of ISO, FDA, MDD and regulations applicable to the design and development of medical device/science/technology.


    • Provides expert input to develop solutions to complex problems that require the regular use of creativity, and originality.


    • Robust process management, problem solving skills and superior presentation capabilities.

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