Senior Embedded Software Engineer

Custom Health; Morrisville (NC); On-site; USD 110,000 - 150,000; Full time

Job summary

Custom Health in Morrisville, NC is seeking a Senior Embedded Software Engineer to develop mission-critical firmware for next-generation medical devices, with emphasis on embedded Linux applications and wireless connectivity.

You will collaborate with hardware engineers, implement low-level drivers, lead debugging, and ensure ISO 13485 and IEC 62304 compliance throughout development.

Qualifications

• Embedded Linux: kernel-space and user-space development, including custom driver development and BSP.
• Wireless Comms: integrating and certifying wireless stacks for commercial products.
• Debugging Prowess: isolating root causes in complex, concurrent systems where hardware and software intersect.
• Education: Bachelor's or Master's in Electrical Engineering, Computer Engineering, or Computer Science.

Responsibilities

• Embedded Linux Development: Design, develop, and maintain custom application and libraries in embedded Linux operating system for SoC architectures.
• Wireless Integration: Implement and optimize wireless communication protocols, including Wi-Fi, Bluetooth/BLE, and Cellular (LTE/5G), ensuring robust connectivity in high-interference environments.
• Hardware: 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.
• Expert Debugging: Lead complex troubleshooting efforts using oscilloscopes, logic analyzers, JTAG/SWD debuggers, and GDB to resolve race conditions, memory leaks, and hardware-software timing issues.
• Compliance & Documentation: 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).
• Documentation: Write and maintain technical documentation, including software design specifications and test procedures
• Security: Practical understanding of secure boot, encryption at rest/transit, and certificate management for connected medical devices.

Skills

Embedded Linux

Wireless Communications

Debugging

C/C++ development

Education

Bachelor's or Master's in Electrical Engineering, Computer Engineering, or Computer Science

Tools

I2C

SPI

UART

USB

Job description

About spencer®

Spencer Health Solutions (www.spencerhealthsolutions.com) 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.

Description

About spencer®

Spencer Health Solutions (www.spencerhealthsolutions.com) 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.

About Custom Health (Parent Owner)

Custom Health provides a comprehensive tech-enabled med management and managed care solution resulting in 98% medication adherence for our patients across the United States and Canada. Operations are powered by proprietary software which orchestrates fully automated owned and network pharmacies, at-home medication management solutions, real-time clinical oversight by 200+ pharmacist-lead clinicians and the collection of real-time, real-world data and insights.

Overview

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.

Key Responsibilities

• Embedded Linux Development: Design, develop, and maintain custom application and libraries in embedded Linux operating system for SoC architectures.
• Wireless Integration: Implement and optimize wireless communication protocols, including Wi‑Fi, Bluetooth/BLE, and Cellular (LTE/5G), ensuring robust connectivity in high-interference environments.
• Hardware: 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.
• Expert Debugging: Lead complex troubleshooting efforts using oscilloscopes, logic analyzers, JTAG/SWD debuggers, and GDB to resolve race conditions, memory leaks, and hardware-software timing issues.
• Compliance & Documentation: 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).
• Documentation: Write and maintain technical documentation, including software design specifications and test procedures
• Security: Practical understanding of secure boot, encryption at rest/transit, and certificate management for connected medical devices.

Requirements

Required Experience & Qualifications

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

Preferred Experience

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