Principal Systems Engineer - Minneapolis - Gateway Recruiting

    Gateway Recruiting
    Gateway Recruiting Minneapolis

    1 week ago

    Description

    Job Summary:
    The Principal Systems Engineer will lead the architecture and integration of active implantable medical devices (AIMDs). This role involves defining system-level requirements, ensuring seamless integration of electrical, mechanical, and software components, and driving compliance with stringent medical device regulations. The ideal candidate will provide technical leadership and collaborate cross-functionally to translate clinical needs into safe, reliable, and manufacturable products.
    Responsibilities:

    • Define and manage system-level requirements, architecture, and interfaces for implantable devices and associated external components.
    • Collect and analyze design inputs (customer needs, business needs, etc.) and transform them into high quality engineering user system requirements and product system specifications.
    • Work with outside development partners to support the system design activities for development projects or programs
    • Lead, coordinate, execute, and document system analysis and design activities including but not limited to architecture definition, interface management, performance modeling, and system integration, etc.
    • Develop and maintain system models, perform trade-off analyses, and optimize constraints such as ultra-low power, biocompatibility, miniaturization, and long-term reliability
    • Oversee verification and validation planning at the system level, including safety testing
    • Collaborate with cross-functional teams to support design reviews, technology roadmaps, and regulatory submissions.
    • Stay current with advancements in implantable systems, including neuromodulation, and telemetry.
    • Mentor junior engineers within the engineering organization and lead technical discussions to ensure robust system design and integration.

    Required Qualifications:

    • Bachelor's degree in Systems Engineering, Electrical Engineering, Biomedical Engineering, or related field
    • 10+ years of experience in system design, architecture and integration for active implantable medical devices (e.g., neurostimulators, pacemakers, defibrillators, cochlear implants, or similar Class II/III devices)
    • Proven track record in medical device development, including full product lifecycle from concept to commercialization
    • Strong knowledge of regulatory requirements for implantable devices and experience with design controls, verification/validation, and risk management

    Preferred Qualifications:

    • Master's or Ph.D. in Systems Engineering, Electrical Engineering or related field
    • Experience with neuromodulation, cardiac rhythm management, or closed-loop implantable systems
    • Familiarity with system modeling tools (e.g., MATLAB/Simulink), requirements management platforms, and interface control documentation
    • Experience leading technical teams, design reviews, FMEA sessions.
    • Participation in regulatory audits

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