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    Senior Product Development Engineer - Atlanta, United States - Biomedical Resource Consultants, Inc

    Biomedical Resource Consultants, Inc
    Biomedical Resource Consultants, Inc Atlanta, United States

    1 week ago

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    Description
    Job Description

    Job Description

    Senior Product Development Engineer
    Position Summary

    :


    Reporting to the VP of Research & Development, you will be responsible for the planning, organization and implementation of the design and development of devices within the company's product portfolio.

    Our client is a late-stage startup, entering ramp-up mode, who is developing a novel women's health technology platform.

    With four products on the market, and one more in late-stage development, they have developed a disruptive technology that is the only known alternative for a procedure that is currently being performed over 700K times a year.

    This hands-on role requires initiative, originality, ingenuity, and excellent problem-solving skills. You must have the ability to adapt and make decisions in a fast-paced environment to meet aggressive deadlines.

    Specific Job Functions:

    Oversee the R&D manufacturing process

    Ensure the timely completion and budget of projects with priorities established and agreed upon with R&D leadership

    Lead or support the conceptualization, planning, and design of new products; Risk assessment; Prototype design and testing; Design reviews; Design verification testing; R&D product manufacturing process development; Product validation and usability testing

    Designs/develops components, products, processes, fixtures, and test systems

    Conducts and/or contracts testing to evaluate components, products and processes

    Creates testing protocols, engineering specifications, drawings, technical reports, and other product documentation

    Provides input on improvements for current manufacturing and/or new processes for future devices. Provides input on new product development initiatives

    Fabricates or oversees production of prototype product, pre-clinical product, and manufacturing equipment/ tooling fabrication

    Procurement of capital equipment and tooling

    Train and guide lower-level engineers and production personnel

    Minimum Qualifications, Education & Work Experience
    Desire and ability to manage R&D Manufacturing as the company grows
    Bachelor's degree in engineering (mechanical/ biomedical) or related scientific field

    5+ years of experience in medical device mechanical design and manufacturing

    2+ years of project management experience in medical device mechanical design and manufacturing

    Hands-on experience with advanced SolidWorks or 3D CAD techniques (e.g. surface modeling)

    Thrives in a fast-paced environment, is motivated and eager to learn

    Excellent time management skills and comfortable working on multiple projects at once

    Experience effectively communicating project concepts, ideas and information
    to supervisors, operators and other team members

    Experience with Medical Device Directive (MDD), ISO 13485, FDA design controls

    Good understanding of product manufacturing, e.g. injection molding, metals and metallic stamping processes, polymers, extrusions, coating technologies, 3D printing, etc.

    Good understanding of Risk Analysis, FMEA, and process validation

    Working knowledge of quality system regulations (FDA and ISO)

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