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    Principal Mechanical Engineer - Alameda, United States - iota Biosciences, Inc.

    iota Biosciences, Inc.
    iota Biosciences, Inc. Alameda, United States

    2 weeks ago

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    Description


    Welcome to an exciting opportunity to join our team as a Principal Mechanical Engineer specializing in active implantable medical devices, particularly neurostimulator devices such as IPGs, Leads, Surgical Tools, and Accessories.

    We are seeking a highly skilled engineer with a deep understanding of industry standards for implantable devices.

    In this role, you will utilize your expertise in CAD, FEA, and failure analysis to drive the design and development of cutting-edge medical devices.

    Additionally, your ability to present to senior leadership will be instrumental in guiding strategic decision-making.

    If you are passionate about pushing the boundaries of medical technology and improving patient outcomes, we invite you to be part of our innovative team.


    Responsibilities:

    • Take ownership of mechanical design projects related to implantable leads and IPGs
    • Lead the design, development, and optimization of implantable components, ensuring compliance with regulatory standards and performance requirements
    • Collaborate closely with cross-functional teams including R&D, electrical engineering, and manufacturing to integrate mechanical solutions into overall product development
    • Drive innovation in mechanical engineering solutions for implantable medical devices, staying abreast of industry trends and emerging technologies
    • Conceptualize and develop novel mechanical designs to enhance the performance, reliability, and manufacturability of implantable leads and IPGs
    • Provide technical leadership and mentorship to junior engineers within the mechanical engineering team
    • Guide and support the team in solving complex engineering challenges, fostering a culture of continuous learning and professional development
    • Collaborate with internal and external stakeholders to identify and address mechanical engineering issues throughout the product lifecycle
    • Work closely with regulatory affairs and quality assurance teams to ensure compliance with relevant standards and regulations
    • Prepare comprehensive design documentation, including technical specifications, engineering drawings, and test plans/reports
    • Communicate project status, progress, and technical insights effectively to key stakeholders and project teams

    Travel ~20%Qualifications:

    • Bachelor's degree in mechanical engineering or related field with 12+ years of experience; or eight plus years of experience with an advanced degree (Master's, PhD) preferred
    • Eight plus years of experience in mechanical engineering, with a focus on medical devices and implantable technologies
    • Proven track record of leading mechanical design projects from concept to commercialization, preferably in a startup or fast-paced environment
    • Expertise in CAD software (e.g., SolidWorks, ProE/Creo) and proficiency in finite element analysis (FEA) tools
    • Strong understanding of materials science, manufacturing processes (machining, stamping, welding, brazing, mold design and fabrication), and design for manufacturability (DFM) principles
    • Excellent knowledge of materials used in the neurostimulation implantable such as MP35, Titanium, Platinum, Palladium, stainless steel and others
    • Knowledge of relevant regulatory requirements and standards for medical devices (e.g., ISO 13485, FDA QSR)
    • Excellent communication skills, both verbal and written, with the ability to effectively collaborate across multidisciplinary teams$180,000 - $220,000 a year
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