Senior Embedded Software Engineer

Custom Health • Morrisville, NC

8d

About The Position

Spencer Health Solutions is transforming healthcare by moving care delivery to the home through the company’s spencer® medication adherence and engagement platform. The spencer FDA Class I technology enables virtual care by connecting patients, clinicians, pharmacists and family members digitally. The Morrisville company offers the right candidate an opportunity to be part of a high-performing team in the development of cutting-edge medical technology at the exciting point of market entry through leading health technology distributors in the US, Canada and Europe. We are looking for a Senior Embedded Software Engineer with deep expertise in Embedded Linux and Wireless Communications to join our R&D team. You will be responsible for developing mission-critical firmware for next-generation medical devices. This role requires a hardware mindset, high-level debugging skills, and a commitment to the rigorous safety standards required in the healthcare industry.

Requirements

• Strong proficiency in kernel-space and user-space development, including custom driver development and board support packages (BSP).
• Proven track record of integrating and certifying wireless stacks for commercial products.
• Highly skilled in isolating root causes in complex, concurrent systems where hardware and software intersect.
• Bachelor’s or Master’s degree in Electrical Engineering, Computer Engineering, or Computer Science.

Nice To Haves

• Direct experience working under FDA/EMA regulatory frameworks and medical-grade quality management systems.
• Familiarity with ISO 14971 (Risk Management), IEC 62304 (Medical Device Software), and IEC 60601 (Safety/Essential Performance).
• Experience with RTOS (FreeRTOS, Zephyr) in addition to Linux is a plus.

Responsibilities

• Design, develop, and maintain custom application and libraries in embedded Linux operating system for SoC architectures.
• Implement and optimize wireless communication protocols, including Wi-Fi, Bluetooth/BLE, and Cellular (LTE/5G), ensuring robust connectivity in high-interference environments.
• Work closely with hardware engineers to bring up Operating systems and Applications on new boards; Write low-level drivers (I2C, SPI, UART, USB) and perform memory mapped I/O operations as necessary.
• Lead complex troubleshooting efforts using oscilloscopes, logic analyzers, JTAG/SWD debuggers, and GDB to resolve race conditions, memory leaks, and hardware-software timing issues.
• Ensure all code and processes adhere to required standards such ISO 13485 and IEC 62304 standard.
• Participate in risk analysis (FMEA) and maintain meticulous design history files (DHF).
• Write and maintain technical documentation, including software design specifications and test procedures.
• Practical understanding of secure boot, encryption at rest/transit, and certificate management for connected medical devices.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior