Manufacturing Engineering Manager - Houston, United States - recruitAbility

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    Description


    Our client is a dedicated Austin-based, private equity-funded, medical device company that offers an innovative, FDA EUA-authorized, rapid PCR, point-of-care system.

    Their product is easy to use, affordable, and provides PCR results in only 15 minutes. They have a vision to enable simple, affordable, rapid, and accurate testing for everyone. They are an incredibly talented and diverse team of scientists, engineers, and experienced professionals who are driven to excel and significantly contribute to the world

    As they continue growing, they are looking for a

    Manufacturing Engineering Manager (Instrument)

    to spearhead engineering endeavors in backing the company's instrument manufacturing and repair operations.

    This individual will oversee all technical and product support facets of instrument manufacturing engineering operations, ensuring adherence to FDA regulations and GMP guidelines.

    What's in it for YOU?

    They offer a fast-paced, exciting, collaborative environment where individual contributions are highly valued as they work to expand the use of transformative testing technology in the market.

    A wonderful company culture with great core values and looking for team players who also align with them - Value Everyone, Ownership, Innovation, Collaboration, and Excellence Driven

    Very exciting time to work with an awesome leadership team that has proven experience commercializing biotech, including expertise in system and assay research and development, regulatory, intellectual property, engineering, and manufacturing.

    This company is in a growth mode and is bound for great things This is an opportunity for you to help make a significant difference with this delivery to the world

    What YOU get to DO at this growing company:
    initiatives for continuous improvement in efficiency and product quality in instrument manufacturing operations.
    technical support, ensure compliance with regulations, and collaborate with QA/QC teams.
    facility and equipment needs, resolve nonconformance issues, and support audits.
    lean principles, conduct evaluations, and promote a safe working environment.

    What you NEED to SUCCEED in this challenging role:
    degree in engineering or a related life science field
    years of experience in technical manufacturing operations, preferably in the medical device sector
    as an Engineering Manager or senior-level engineer.
    with FDA regulations and GMP guidelines is desirable.
    problem-solving skills, the ability to drive process improvements, collaborate effectively, work independently, and prioritize tasks are essential.
    in Microsoft Office Suite and facility navigation is required.

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