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Manufacturing Test Engineer

Katalyst Healthcares & Life Sciences

  • Blue Ash, OH
  • 30+ days ago

    Highlights

    The ideal candidate will have experience supporting prototype and production equipment, developing test procedures, troubleshooting systems, and ensuring smooth transition of products into manufacturing operations. Job Summary: We are seeking a skilled Manufacturing Test Engineer to support testing, validation, equipment setup, and process development activities within a regulated manufacturing environment.

    Numbers & Facts

    LocationBlue Ash, OH

    Description

    Job Summary:
    • We are seeking a skilled Manufacturing Test Engineer to support testing, validation, equipment setup, and process development activities within a regulated manufacturing environment. The ideal candidate will have experience supporting prototype and production equipment, developing test procedures, troubleshooting systems, and ensuring smooth transition of products into manufacturing operations.
    • The candidate should possess strong knowledge of manufacturing engineering support, equipment validation, process qualification, documentation practices, and medical device regulatory requirements.
    Roles & Responsibilities:
    • Set up, execute, and document test configurations for components, assemblies, and manufacturing equipment.
    • Develop, refine, and optimize test procedures, protocols, and validation methods to improve testing efficiency and product quality.
    • Build, maintain, troubleshoot, and operate prototype and production equipment.
    • Support installation, startup, debugging, qualification, and validation activities for new products and manufacturing equipment.
    • Collaborate with suppliers, engineering, quality, and operations teams to ensure equipment and components meet design and production specifications.
    • Support smooth transition of new products and processes into manufacturing environments.
    • Maintain detailed technical documentation including SOPs, validation records, test reports, component specifications, and process documentation.
    • Provide onboarding, training, and technical guidance to testing and process personnel.
    • Manage equipment, components, inventory, and procurement activities to support project timelines and production schedules.
    • Support process development, equipment qualification, assembly process validation, and software-driven manufacturing systems.
    • Ensure compliance with manufacturing quality standards, regulatory requirements, and internal procedures.
    Education & Experience:
    • Bachelor's degree in engineering, Manufacturing, Biomedical Engineering, Mechanical Engineering, or related technical field preferred.
    • 3+ years of experience in manufacturing test engineering, process engineering, or equipment validation environments.
    • Experience in regulated manufacturing or medical device industries preferred.
    • Equivalent combination of education and relevant work experience will also be considered.

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