Position OverviewThe Electrical Engineer - Health Sensing will be responsible for the design, development, and validation of embedded hardware and firmware systems that power Zywie's wearable cardiac monitoring devices. This role requires a technically versatile engineer who is comfortable working across analog circuit design, embedded firmware, and regulatory documentation in a fast-paced medical device environment. The ideal candidate brings hands-on experience with low-power IoT systems, biosignal acquisition, and FDA-regulated product development.
Key Responsibilities- Design and develop real-time firmware and hardware for Zywie's wearable cardiac monitoring devices, including Holter, event, and mobile cardiac telemetry monitors.
- Develop and optimize embedded firmware using real-time operating systems such as Zephyr or FreeRTOS for continuous biosignal acquisition and transmission.
- Design and review circuit board schematics and PCB layouts for low-power IoT embedded systems incorporating sensors, BLE microcontrollers, memory, and power management circuits.
- Implement and validate analog and digital signal processing pipelines for high-fidelity ECG signal capture and analysis.
- Utilize debugging and testing equipment - including oscilloscopes, logic analyzers, DMMs, and embedded debuggers - to validate firmware and hardware performance.
- Implement and troubleshoot communication protocols including SPI, I2C, UART, and QSPI between system components.
- Author and maintain technical documentation including design specifications, test protocols, and verification and validation (V&V) reports in compliance with FDA regulatory requirements.
- Collaborate cross-functionally with hardware, mobile, cloud software, and clinical teams to develop and validate integrated patient monitoring solutions.
- Participate in design reviews, risk analysis, and design history file (DHF) activities consistent with ISO 13485 and FDA 21 CFR Part 820 quality systems.
- Support continuous improvement efforts by identifying opportunities to enhance device performance, power efficiency, and signal quality.
Required Qualifications- Bachelor's degree in Electrical Engineering, Computer Engineering, or a closely related field; Master's degree or higher strongly preferred.
- Minimum 2 years of experience in hardware and firmware development for wearable or embedded systems.
- Proficiency with real-time embedded operating systems, specifically Zephyr or FreeRTOS.
- Strong command of embedded communication protocols: SPI, I2C, UART, and QSPI.
- Experience with low-power circuit design including BLE microcontrollers, analog front-end (AFE) circuits, sensors, and power management ICs.
- Solid understanding of analog and digital filter design and analog-to-digital conversion for biosignal applications.
- Programming proficiency in C/C++; working knowledge of Python, Java, or MATLAB.
- Familiarity with electronic test and measurement equipment including oscilloscopes, logic analyzers, and debuggers.
- Strong technical writing skills with experience preparing engineering documentation.
Preferred Qualifications- Experience designing or validating FDA-regulated medical devices (Class II preferred).
- Knowledge of ISO 13485, IEC 60601, or IEC 62304 standards.
- Background in ECG, PPG, or other biosignal acquisition and processing.
- Experience with Bluetooth Low Energy (BLE) protocol stacks and wireless data transmission for medical applications.
- Familiarity with design history files (DHF), risk management documentation (ISO 14971), and V&V test planning.
