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    Tooling Engineer - Fremont, United States - BioTalent

    BioTalent
    BioTalent Fremont, United States

    2 weeks ago

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    Description

    Medical Device Tooling Engineer

    We are seeking a highly motivated and detail-oriented Medical Device Tooling Engineer to join our growing team. In this critical role, you will play a key part in ensuring the successful design, development, and implementation of tooling for the production of complex medical devices within a contract manufacturing environment.

    Responsibilities:

    • Collaborate with design engineers and project managers to develop and optimize tooling for the production of medical devices using plastics injection molding processes.
    • Utilize CAD software (e.g., SolidWorks, Creo) to design and detail tooling components, including molds, fixtures, and gauges, ensuring compliance with engineering specifications and industry standards.
    • Conduct manufacturability reviews of tooling designs, identifying potential issues and proposing solutions to optimize production efficiency and product quality.
    • Perform Failure Mode and Effects Analysis (FMEA) to identify and mitigate potential risks associated with tooling design and manufacturing processes.
    • Work closely with moldmakers and other manufacturing personnel to ensure accurate and timely fabrication of tooling.
    • Participate in tool trials and qualifications, conducting inspections and analyzing data to verify functionality and adherence to specifications.
    • Maintain thorough documentation of tooling design, development, and qualification processes.
    • Stay up-to-date on industry best practices and regulatory requirements for medical device manufacturing.

    Qualifications:

    • Bachelor's degree in Mechanical Engineering or a related field.
    • Minimum 3 years of experience in medical device tooling design and development.
    • Proven experience with plastics injection molding processes, including mold design principles, material selection, and processing parameters.
    • Proficiency in CAD software (SolidWorks, Creo, or similar).
    • Strong understanding of GD&T (Geometric Dimensioning & Tolerancing) principles.
    • Excellent analytical and problem-solving skills.
    • Effective communication and collaboration skills.
    • Ability to work independently and manage multiple projects simultaneously.
    • Meticulous attention to detail and a commitment to quality.
    • Experience with FMEA and other quality control principles a plus.

    Benefits:

    • Competitive salary and benefits package.
    • Opportunity to work on cutting-edge medical device technologies.
    • Fast-paced and dynamic work environment.
    • Be part of a team that is making a positive impact on patient lives.
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