ZYWIE INC

Company Overview Founded in 2014, Zywie Healthcare is a cardiac monitoring company dedicated to putting doctors' offices and hospitals in complete control of patient care. Through our Holter, event, and mobile cardiac telemetry (MCT) monitors, we record and transmit patients' EKGs with precision and reliability. As we expand beyond cardiac monitoring toward becoming the gold standard for patient care, we are growing our engineering team with talented individuals who want to build technology that makes a real difference. Position Overview The 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. PIcc6ef5-