Principal Embedded Engineer, Medical Devices (Hybrid)

Trilyon, Inc.; Waltham (MA); Hybrid; USD 150,000 - 190,000; Full time

Job summary

Trilyon, Inc. in Waltham, MA is seeking a Principal Embedded Engineer to lead embedded software for regulated medical devices. You will architect, implement, and maintain firmware and software across the lifecycle in a hybrid work setting.

You’ll collaborate with Systems, Electrical, QA, Regulatory, and Manufacturing to ensure traceability, risk management, and compliance with IEC 62304 and FDA guidance, while mentoring engineers and driving technical excellence.

Qualifications

• Bachelor’s or Master’s degree in Computer Science, Software Engineering, Computer Engineering, Electrical Engineering, Biomedical Engineering, or a related technical discipline.
• Typically 10–15+ years of professional embedded software or firmware development experience.
• Experience operating at Principal Engineer, Senior Staff Engineer, Software Architect, or equivalent leadership level.
• Strong hands-on experience developing embedded software in C and/or C++.
• Experience developing software for regulated medical devices, IVD systems, healthcare products, or another safety-critical regulated industry.
• Experience with complete embedded software lifecycle: requirements, architecture, design, implementation, integration, verification, release, maintenance.
• Strong understanding of embedded-system architecture and hardware-software interaction.
• Experience debugging complex embedded systems with hardware/software tools.
• Experience developing multithreaded, real-time, or event-driven embedded applications.
• Experience with embedded operating systems, embedded Linux, or RTOS.
• Experience with device drivers, hardware abstraction, communication interfaces, peripheral integration.
• Knowledge of software architecture, modular design, state machines, memory management, concurrency, fault handling.
• Experience with source control, configuration management, code reviews, defect tracking, and releases.
• Ability to analyze and improve large or legacy embedded codebases.
• Experience producing software lifecycle documentation and traceability.

Responsibilities

• Provide technical leadership for embedded software development and sustaining-engineering activities.
• Design, implement, debug, test, and maintain embedded software and firmware for medical devices.
• Define and evolve embedded software architecture, component boundaries, interfaces, and data flows.
• Analyze legacy software to understand behavior, architecture, dependencies, and limitations.
• Resolve complex software, firmware, hardware-integration, performance, reliability, and field issues.
• Translate system and product requirements into testable software requirements and designs.
• Decompose system requirements into embedded software components and interfaces.
• Ensure alignment between requirements, architecture, design, risk controls, and verification.
• Lead technical reviews, design reviews, code reviews, and root-cause investigations.
• Collaborate with electrical and systems engineers on interfaces, sensors, protocols, diagnostics.
• Develop low-level drivers, device-control logic, HALs, and application-level embedded functionality.
• Support integration with external systems such as middleware, host apps, hospital networks, or cloud services.
• Perform impact analysis for changes and cybersecurity vulnerabilities.
• Create/update software lifecycle documentation and ensure traceability.
• Mentor engineers and drive continuous improvement of processes and tools.

Skills

Advanced C/C++

Embedded Linux/RTOS

Multithreaded real-time

Hardware-software interaction

Regulatory/compliance awareness

Technical leadership

Strong English communication

Education

Bachelor’s or Master’s degree in related field

Tools

JTAG

Oscilloscopes

Logic analyzers

Cross-compilation toolchains

CI/CD pipelines

Version control systems

Job description

Trilyon, Inc. in Waltham, MA is seeking a Principal Embedded Engineer to lead embedded software for regulated medical devices. You will architect, implement, and maintain firmware and software across the lifecycle in a hybrid work setting.

You’ll collaborate with Systems, Electrical, QA, Regulatory, and Manufacturing to ensure traceability, risk management, and compliance with IEC 62304 and FDA guidance, while mentoring engineers and driving technical excellence.