Senior Hardware/Firmware Engineer

This role will lead multiple concurrent initiatives, ensure delivery of reliable, scalable, and compliant hardware and embedded systems while leveraging modern development practices, including AI-assisted engineering, within a regulated Quality Management System (QMS), * Lead hardware and firmware architecture, design, and development for embedded medical devices across multiple platforms

• Own the end-to-end hardware/firmware lifecycle: requirements, design, implementation, verification, and release
• Drive technical strategy, including platform scalability, reuse, and long-term maintainability
• Manage device design project execution with backlog ownership, sprint planning, risk tracking, and cross-team visibility
• Partner closely with Engineering, Mobile Software, Quality, Regulatory, Manufacturing, and Clinical teams
• Collaborate with the in-house mobile team to build and improve the device-app interface, BLE protocol definition, OTA update delivery, and usage-data synchronization contracts
• Ensure compliance with IEC 60601, IEC 62304 (including software safety classification), FDA design controls, and internal QMS requirements
• Lead risk management (ISO 14971), traceability, and verification strategies across hardware design and firmware systems
• Implement product cybersecurity consistent with FDA premarket cybersecurity expectations (Section 524B): threat modeling, SBOM generation and maintenance, secure boot, and signed firmware updates
• Mentor and guide engineers; provide technical oversight and code review leadership
• Drive root cause analysis (RCA), corrective actions (CAPA), and continuous improvement initiatives
• Champion AI-assisted development to improve productivity, quality, and documentation

Do you have experience in Printed circuit board (PCB) layout?, Do you have a Bachelor's degree?, * Medical device or other regulated industry experience

• Altium Designer expertise
• Design and development with low power microcontrollers
• Experience with developing battery-operated devices with low power consumption
• Programming experience in C, C++ and Python
• Familiar with Github, Gitlab and version control within a regulated environment
• IEC 60601 medical device requirements and testing
• IEC 62304 lifecycle, verification, and traceability expertise
• ISO 14971 risk management integration
• FDA premarket cybersecurity documentation (threat models, SBOM, security risk assessment)
• Experience with closed-loop control systems
• Multi-product platform strategy and reuse
• Advanced debugging and system-level troubleshooting
• AI-assisted development tools in regulated environments, * Bachelor's degree in Electrical Engineering or Computer Engineering (MS or PhD preferred)
• 5-10+ years of professional hardware/embedded firmware development experience
• Proven ownership of hardware/firmware design and development across the full product lifecycle
• Strong experience with BLE, RTOS, and embedded debugging tools
• Strong electronic component selection experience and analog/digital electrical design capability
• Experience with schematic capture and PCB design; Altium experience preferred
• Experience with hardware bring-up, validation, and system-level debug
• Experience working with MCUs, BLE interface design and/or embedded electronic control systems
• Experience with communication interfaces such as I2C, SPI, CAN, USB, LVDS or MIPI
• Ability to support projects from concept through production using a structured development process
• Strong technical communication skills and ability to interface directly with customers
• Ability to work effectively as an individual contributor in a multi-discipline engineering environment
• Experience working within regulated or quality-managed environments
• Expertise in regulated medical device development (IEC 60601, IEC 62304, design controls)
• Willingness to periodically travel to collaborate with outside suppliers, * Bachelor's (Required)

Experience:

• Professional hardware/embedded firmware development: 5 years (Required)

Ability to Commute:

• Wake Forest, NC 27587 (Required)

Pulled from the full job description

• Health insurance
• 401(k) matching
• Paid time off
• Vision insurance
• Dental insurance, Why You'll Love Working at Signifier Medical Technologies
• Mission-driven work that directly improves patients' quality of life.
• Supportive, collaborative, family-oriented culture.
• Opportunity to shape and scale a rapidly growing team.
• Meaningful impact across the patient journey and the future of sleep health.
• Growth opportunities as our company expands nationally.

Pay: $130,000.00 - $155,000.00 per year, * 401(k) matching

• Dental insurance
• Health insurance
• Paid time off
• Vision insurance

Signifier Medical Technologies is a fast-growing medical technology company advancing clinically validated, non-invasive therapies for sleep-disordered breathing, including snoring and mild sleep apnea. We develop and deliver solutions such as eXciteOSA®, the first daytime therapy designed to target a root cause of sleep-disordered breathing, supporting patients and healthcare providers nationwide. Our focus is practical innovation-improving access to effective sleep health solutions today while building a durable platform for the future of care.