Lead Systems Engineer - San Carlos - Russell Solutions Group

    Russell Solutions Group
    Russell Solutions Group San Carlos

    1 week ago

    Description

    Position Overview

    We are seeking a talented and motivated Senior Embedded Systems Engineer to join our team full-time at our Bay Area facility. This is an on-site position offering hands-on experience with cutting-edge medical device technology.

    In this role, you will lead the development of the uLink external console as we prepare for design freeze, OUS regulatory submission and first-in-human clinical deployment. You'll take technical ownership of the device's critical sub-system while collaborating with our multidisciplinary engineering team to deliver a safe and reliable external device.

    The ideal candidate thrives in dynamic startup environments, brings strong organizational and technical skills combined with a collaborative mindset, and is excited by the opportunity to make meaningful contributions to a product that will directly impact patient lives. This position offers the chance to shape the future of our technology and organization for the right individual.

    Roles and Responsibilities


    • Drive the uLink external console from advanced prototype through design verification and OUS regulatory submission to first-in-human clinical trials


    • Work with external service providers to manage electrical and mechanical component supply, device builds, testing and inspections


    • Own verification and validation (V&V) activities including managing external testing services for console related tests (Electrical Safety Testing, EMC Testing, etc.)


    • Ensure compliance with applicable regulatory standards (IEC 60601, etc.) and internal quality requirements


    • Lead technical troubleshooting and implement innovative solutions to enhance device performance, reliability, patient safety and manufacturability


    • Establish and maintain rigorous design documentation and traceability within the company's Quality Management System


    • Draft test protocols and reports for various console related DV and characterization tests


    • Contribute to cross-functional design reviews and risk assessments to drive product maturation toward clinical milestones

    Required Qualifications


    • B.S. in Electrical Engineering, Computer Engineering, or related technical field


    • Proven track record developing electronic embedded systems for medical devices


    • 5+ years in medical device development with demonstrated experience working under FDA QSR, ISO 13485, or equivalent quality systems


    • Working knowledge of design controls, risk management (ISO 14971), safety and performance standards (IEC and regulatory pathways for medical devices


    • Experience managing component suppliers and external manufacturers


    • Hands-on prototyping capabilities spanning firmware, software and user interface design for medical devices


    • Background in digital signal processing or related analytical techniques


    • Demonstrated proficiency with electrical test equipment such as oscilloscopes, function generators, power supplies, and multimeters


    • Self-directed problem solver with ability to balance independent technical work and collaborative cross-functional initiatives


    • Clear technical communicator with strong documentation practices


    • Prior role in an early-stage medical device company or startup environment

    Preferred Qualifications


    • Proficiency in C, C++, C# or Python for embedded software development and integration


    • Experience with Verilog, System Verilog or VHDL for FPGA development


    • Experience with electronic hardware development for medical devices


    • Knowledge of IEC 60601 requirements and tests for medical electrical equipment


    • Experience with ultrasound systems, ultrasound imaging, or related technologies


    • Familiarity with wireless powering and data communication systems

    What We Offer


    • Meaningful Impact on life-saving cardiac technology


    • Growth Opportunity with increasing responsibility as we scale


    • Collaborative Culture with experienced medical device professionals


    • Competitive Compensation including equity participation and PTO


    • Comprehensive Benefits including health, dental, and vision coverage

    Location & Work Environment

    This is a full-time, on-site position based in the Bay Area, California. Our collaborative work environment emphasizes hands-on development, rapid iteration, and close teamwork. While we value work-life balance, the fast-paced nature of startup development occasionally requires flexibility in working hours to meet critical milestones.

    This position will require minimal travel outside of Bay Area, California.

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