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Agent guide: [/agents.md](https://www.wearedevelopers.com/agents.md). --- # Senior Hardware/Firmware Engineer - **Company:** Signifier Medical Technologies LLC - **Location:** Wake Forest, NC, United States - **Experience:** Expert - **Salary:** $130,000.0 - $155,000.0 - **Contract:** Permanent contract - **Skills:** Board Bringup, C (Programming Language), Artificial Intelligence, Altium Designer, C++ (Programming Language), Code Review, Computer Programming, Computer Engineering, Data Synchronization, Software Debugging, Embedded Software, Firmware, Github, Design of User Interfaces, Hardware Design, Mobile Application Software, Python (Programming Language), Scrum Methodology, Real-Time Operating Systems, Software Safety, Schematic Capture, PIC Microcontroller, Gitlab, Software Version Control - **Published:** June 24, 2026 - **Apply:** https://www.indeed.com/viewjob?jk=4941d89f0a1fdb7d ## About the Role 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) ## Description 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 ## Related Videos - [Playing Pong on a shoulder press machine](https://www.wearedevelopers.com/videos/100140-playing-pong-on-a-shoulder-press-machine) - [Innovating Developer Tools with AI: Insights from GitHub Next](https://www.wearedevelopers.com/videos/1268-innovating-developer-tools-with-ai-insights-from-github-next) - [WeAreDevelopers LIVE - Modern DevOps for IoT Devices and More](https://www.wearedevelopers.com/videos/1805-wearedevelopers-live-modern-devops-for-iot-devices-and-more) - [More efficient software for more efficient microchips](https://www.wearedevelopers.com/videos/1164-more-efficient-software-for-more-efficient-microchips) - [Agent Smith Gets Hardware: Autonomous IoT Hacking From Debug Port to Cloud API](https://www.wearedevelopers.com/videos/100258-agent-smith-gets-hardware-autonomous-iot-hacking-from-debug-port-to-cloud-api) - [Bringing AI Model Testing and Prompt Management to Your Codebase with GitHub Models](https://www.wearedevelopers.com/videos/1536-bringing-ai-model-testing-and-prompt-management-to-your-codebase-with-github-models) ## Related Articles - [Fully Remote Software Engineer Jobs](https://www.wearedevelopers.com/magazine/447-fully-remote-software-engineer-jobs) - [Where To Find Software Engineering Jobs](https://www.wearedevelopers.com/magazine/396-where-to-find-software-engineering-jobs) - [Where to Find Entry-Level Software Engineering Jobs](https://www.wearedevelopers.com/magazine/397-where-to-find-entry-level-software-engineering-jobs) - [Why Attend a Developer Event in 2026?](https://www.wearedevelopers.com/magazine/688-why-attend-a-developer-event-in-2026) - [Is Software Engineering Hard?](https://www.wearedevelopers.com/magazine/448-is-software-engineering-hard) - [Welcome to Switzerland](https://www.wearedevelopers.com/magazine/4-welcome-to-switzerland)