Principal Embedded Systems Engineer

Job Title: Principal Embedded Systems Engineer

Location :            Andover, MA (Onsite)

Company Overview :

Digital Health Solutions is a premier medical device consulting firm partnering with MedTech innovators to provide end-to-end product development from concept through regulatory clearance and contract manufacturing. With our ISO 13485 certification and deep expertise in IEC 62304, ISO 14971, and FDA’s guidance document on Cybersecurity, our team helps clients navigate the full complexity of regulated medical device development, bringing innovative technologies to market efficiently, safely, and compliantly.

Role Description:

This full-time, on-site Principal Embedded Systems Engineer role is based in Andover, MA. We are seeking a skilled and hands-on Principal Embedded Systems Engineer to lead the design and development of embedded hardware and firmware systems, spanning microcontroller and microprocessor-based solutions. The ideal candidate will have at least 10 years of experience in embedded systems development, particularly in medical devices or other highly regulated industries. This role will be instrumental in designing high-reliability embedded architectures, ensuring compliance with medical device standards (IEC 62304, ISO 13485, FDA 21 CFR Part 820), and guiding development teams through full product lifecycles.

Responsibilities:

• Strong expertise in embedded systems design and development, including Embedded Software and Firmware Development for real-time and safety-critical applications.
• Architect and oversee development of embedded systems that use 32-bit microcontrollers (STM32, NXP, TI) and application processors (ARM Cortex-A, i.MX, etc.).
• Drive the complete product life-cycle—concept, requirements capture, architecture, design, implementation, verification, release, and long-term maintenance.
• Collaborate with hardware, software, quality, and regulatory teams to translate product requirements and constraints into robust system architectures.
• Lead firmware development in C and C++ for bare-metal, RTOS, and embedded-Linux targets, including board support packages, bootloaders, and secure update mechanisms.
• Define board-level hardware architecture—power, sensing, and communication subsystems (UART, SPI, I²C, CAN, USB, BLE, Wi-Fi, cellular)—in partnership with hardware engineers.
• Perform system bring-up, low-level debugging, and integration of BSPs, device drivers, and middleware.
• Ensure compliance with FDA regulations, ISO 13485, IEC 62304, and cybersecurity guidance (AAMI TIR57, FDA Premarket Cybersecurity).
• Lead risk-management activities, including hazard analysis, FMEA, and verification / validation planning and execution.
• Evaluate and recommend embedded platforms, SoCs, and communication protocols that best meet technical, cost, and schedule objectives.
• Conduct design and code reviews, establish best practices, and mentor junior engineers.
• Produce and maintain high-quality documentation: system architecture specifications, design rationales, test protocols, and risk analyses.

Qualifications :

• 10+ years of hands-on experience in embedded systems development, preferably in regulated industries such as medical devices, aerospace, automotive, or industrial safety.
• Proficient in C and C++ for real-time, safety-critical, and low-level systems.
• Deep expertise in embedded Linux development, including Yocto, Buildroot, kernel customization, and driver integration.
• Strong experience with RTOS (e.g., FreeRTOS, Zephyr, QNX) and bare-metal firmware.
• Proven background in technical consulting or client-facing product development roles.
• Solid understanding of ARM Cortex-M/A architectures, embedded security, and peripheral interfaces.
• Skilled in using debugging and diagnostic tools such as oscilloscopes, logic analyzers, and JTAG/SWD debuggers.
• Familiar with relevant standards and regulatory frameworks, including IEC 62304, ISO 14971, and FDA software validation.
• Experience with wireless protocols (BLE, Wi-Fi, LoRa) and embedded cybersecurity practices.
• Excellent leadership, communication, and documentation skills.
• Strong problem-solving mindset and collaborative approach to innovation.

What We Offer:

• Competitive salary and benefits package, including health insurance, 401(k) plan with employer match, vision, dental and paid time off.
• Opportunity to work with cutting-edge technology in the medical device industry.
• A supportive, collaborative work environment that fosters professional growth and development.
• The chance to make a meaningful impact on the safety and effectiveness of medical devices, ultimately improving patients' lives.