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Engineer III

Katalyst Healthcares & Life Sciences

  • North Chicago, IL
  • 30+ days ago

    Highlights

    Exceptional written and verbal communication skills, and the ability to clearly articulate development challenges and implementation strategies to stakeholders across a broad range of functional groups at all levels of the organization, including external vendors. Roles& Responsibilities: The Combination and Medical Device Products Consumable Device US team is expanding its support for on-market devices.

    Numbers & Facts

    LocationNorth Chicago, IL

    Description

    Roles& Responsibilities:
    • The Combination and Medical Device Products Consumable Device US team is expanding its support for on-market devices.
    • This role will be responsible for on-market change execution, product lifecycle management, and manufacturing support specific to the product design.
    • Proficiency with medical device/pharmaceutical DHF traceability is required.
    • Proficiency with test execution, deviation reporting and management, data review, and report writing is required.
    • Experience with medical device EU and/or FDA regulations is required.
    • In addition to product support, you will also be responsible for standardizing and simplifying activities within the team to enable more efficient development and marketed product support.
    Education & Experience:
    • Bachelor of Science degree with 3+ years of experience in medical device or pharmaceutical development roles.
    • Graduate degree in a technical or scientific field. Prior experience in consumable medical device/pharmaceutical development.
    • Medical device/pharmaceutical development, office, and laboratory settings.
    • Design History File product lifecycle management experience
    • Engineering degree in bioengineering, chemical engineering, or mechanical engineering
    • On-market supplier changes.
    • Knowledge of applicable global regulatory requirements and industry standards (MDR requirements, ISO 13485, ISO 14971, ISO 10993, etc.)
    • Exceptional written and verbal communication skills, and the ability to clearly articulate development challenges and implementation strategies to stakeholders across a broad range of functional groups at all levels of the organization, including external vendors.

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