Senior Embedded Firmware Engineer

NuPulseCV
  • Raleigh, NC
    1 day ago

    Job Description

    Job Description

    Job Description

    About the role

    NuPulseCV is developing a portable circulatory support system that allows advanced heart failure patients to leave the hospital and remain ambulatory while awaiting transplant.

    We are looking for a Senior Embedded Firmware Engineer to own system firmware from architecture through verification and regulatory documentation. This is a hands-on role on a small team, with direct visibility into design controls, risk management, and FDA submissions.

    What you'll do:

    •    Design, implement, and maintain real-time embedded firmware in C on 32-bit microcontrollers.

    •    Develop and tune closed-loop real-time control algorithms, including timing-critical actuation, sensor acquisition, and fault detection.

    •    Use MATLAB and Simulink for model-based design, algorithm development, and simulation, and carry those models through to production.

    •    Implement and verify safety-related firmware functions, including watchdogs, fault monitoring, and safe-state behavior.

    •    Integrate wireless connectivity modules and their host-side drivers and protocol stacks.

    •    Write and maintain lifecycle documentation per IEC 62304: software development plan, requirements specifications, architecture and detailed design, unit/integration/system verification protocols and reports, and requirements-to-test traceability.

    •    Participate in risk management activities - hazard analysis, software FMEA, and derivation of risk control measures traceable to firmware requirements.

    •    Manage SOUP/OTS software: selection, justification, anomaly review, and version control.

    •    Support cybersecurity documentation, including threat modeling and SBOM generation.

    •    Perform and document code reviews, static analysis, and defect tracking under a configuration management system.

    •    Support design verification activities, including root-cause investigation and firmware mitigations.

    •    Contribute to responses to regulatory questions and internal/external audits.



    Required qualifications

    •    Computer Science degree, or equivalent depth of hands-on firmware experience.

    •    7+ years of professional embedded firmware development in C.

    •    Demonstrated experience with real-time, safety-critical, or otherwise high-reliability embedded systems.

    •    Strong bare-metal peripheral work: I2C, SPI, UART, ADC, PWM, DMA, timers, and interrupt design.

    •    Experience integrating wireless modules: BLE, LTE, Wi-Fi, or similar including AT/host command interfaces and connectivity fault handling.

    •    Hands-on debug skills: JTAG/SWD, oscilloscope, logic analyzer, and comfort working alongside hardware engineers.

    •    Experience writing to a documented coding standard and working under formal configuration management and change control.

    •    Clear technical writing. Willingness to spend meaningful time on documentation, not only code.

    Preferred qualifications:

    •    Medical device firmware experience, particularly Class II or Class III.

    •    Working knowledge of IEC 62304 software lifecycle processes.

    •    Familiarity with ISO 14971 risk management and ISO 13485 quality systems.

    •    Experience under FDA design controls (21 CFR 820.30) and contribution to IDE, 510(k), or PMA submissions.

    •    Motor control or other real-time closed-loop actuation experience.

    •    Battery management, smart battery packs, and power path design.

    •    Bio-signal acquisition and digital filtering.

    •    Experience supporting clinical trial firmware maintenance.

    \nCompany Description

    NuPulseCV is developing a portable, battery-powered intra-aortic balloon pump that allows advanced heart failure patients to leave the hospital and remain ambulatory while awaiting transplant.

    Company Description

    NuPulseCV is developing a portable, battery-powered intra-aortic balloon pump that allows advanced heart failure patients to leave the hospital and remain ambulatory while awaiting transplant.

    Numbers & Facts

    LocationRaleigh, NC

    Skills

    • Algorithmsunmatched
    • Boundary Scanunmatched
    • Bug Tracking/Defect Managementunmatched
    • C Programming Languageunmatched
    • Change Controlunmatched
    • Clinical Supportunmatched
    • Clinical Trialunmatched
    • Code Reviewsunmatched
    • Code of Federal Regulationsunmatched
    • Computer Engineeringunmatched
    • Computer Firmwareunmatched
    • Computer Scienceunmatched
    • Configuration Managementunmatched
    • Congestive Heart Failureunmatched
    • Debugging Skillsunmatched
    • Design Verificationunmatched
    • Documentationunmatched
    • Embedded Systemsunmatched
    • External Auditunmatched
    • FDA (Food and Drug Administration)unmatched
    • Failure Mode and Effects Analysis (FMEA)unmatched
    • Fault Managementunmatched
    • Filter Theoryunmatched
    • Hazard Analysisunmatched
    • High Reliabilityunmatched
    • Hospitalunmatched
    • I2Cunmatched
    • IDE (Integrated Development Environment)unmatched
    • ISO (International Organization for Standardization)unmatched
    • Internal Auditunmatched
    • International Electro-Technical Commission (IEC)unmatched
    • Internet Securityunmatched
    • Logic Analyzerunmatched
    • MATLABunmatched
    • Medical Equipmentunmatched
    • Microcontrollerunmatched
    • Motor Control Systemsunmatched
    • Network Debuggingunmatched
    • Oscilloscopeunmatched
    • Protocol Stackunmatched
    • Realtime Operating Systemunmatched
    • Regulationsunmatched
    • Risk Analysisunmatched
    • Risk Managementunmatched
    • Root Cause Analysisunmatched
    • Simulationunmatched
    • Software Developmentunmatched
    • Software Development Lifecycle (SDLC)unmatched
    • Source Code/Configuration Management (SCM)unmatched
    • Static Analysisunmatched
    • Support Documentationunmatched
    • System Architectureunmatched
    • Systems Engineeringunmatched
    • Technical Writingunmatched
    • Threat Modelingunmatched
    • Traceabilityunmatched
    • Universal Asynchronous Receiver-Transmitter (UART)unmatched
    • Wi-Fiunmatched
    • Wireless Communicationsunmatched

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