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. The system is a Class III, life-supporting device.
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. The system is a Class III, life-supporting device intended for 24/7 use in both professional and home healthcare environments.
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. The system is a Class III, life-supporting device intended for 24/7 use in both professional and home healthcare environments.