Embedded Engineer

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

Job Title: Principal Embedded Engineer (Medical Device)

Location: Waltham, MA (Hybrid) (Temp to permanent opportunity)

Job Description

Required 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.
• Demonstrated experience operating at Principal Engineer, Senior Staff Engineer, Software Architect, or equivalent technical-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 the complete embedded software lifecycle, including requirements, architecture, design, implementation, integration, verification, release, and maintenance.
• Strong understanding of embedded-system architecture and hardware-software interaction.
• Experience debugging complex embedded systems using appropriate hardware and software tools.
• Experience developing and maintaining multithreaded, real-time, or event-driven embedded applications.
• Experience with embedded operating systems, embedded Linux, or real-time operating systems.
• Experience with device drivers, hardware abstraction, communication interfaces, and peripheral integration.
• Strong understanding of software architecture, modular design, state machines, memory management, concurrency, and fault handling.
• Experience with source control, configuration management, code reviews, defect tracking, and controlled software releases.
• Ability to analyze and improve large or legacy embedded codebases.
• Experience producing high-quality technical and software lifecycle documentation.
• Strong analytical, troubleshooting, and root-cause-analysis skills.
• Ability to lead technical work through influence without direct management authority.
• Excellent written and verbal English communication skills.

Embedded Technical Skills:

• Advanced C and/or C++ development.
• Embedded Linux and/or RTOS development.
• Multithreaded and real-time software design.
• Low-level firmware and device-driver development.
• Board bring-up and hardware-software integration.
• Inter-process communication and event-driven architectures.
• Serial and hardware communication protocols such as UART, SPI, I²C, USB, CAN, or Ethernet.
• Network communication and device-connectivity protocols.
• Memory, performance, timing, and resource optimization.
• Error handling, fault detection, diagnostics, logging, and recovery mechanisms.
• Unit testing, integration testing, static analysis, and code-coverage analysis.
• Debugging tools such as JTAG, oscilloscopes, logic analyzers, protocol analyzers, and embedded debuggers.
• Build systems, cross-compilation toolchains, and CI/CD pipelines.
• Secure coding and embedded cybersecurity principles.

Medical-Device Responsibilities:

• Develop software in compliance with applicable quality-system procedures.
• Ensure that embedded software development follows IEC 62304 lifecycle processes.
• Support software safety classification and risk-based development activities.
• Contribute to hazard analysis and software-related risk assessment.
• Implement and document software risk-control measures.
• Maintain traceability between requirements, risks, architecture, implementation, and verification.
• Produce or review software development plans, requirements, architecture, detailed designs, test documentation, anomaly assessments, and release records.
• Support Design History File creation and remediation.
• Ensure unresolved software anomalies are properly evaluated and documented.
• Support software validation, regulatory submissions, audits, and inspections.
• Contribute to cybersecurity threat analysis, vulnerability assessment, and remediation.

Regulatory and Standards Experience

Practical experience with several of the following:

• IEC 62304.
• ISO 13485.
• ISO 14971.
• FDA Design Controls.
• FDA 21 CFR Part 820.
• FDA guidance for medical-device software.
• IEC 62366-1.
• FDA cybersecurity guidance.
• EU MDR or IVDR.
• Secure software-development lifecycle practices.
• Medical-device verification and validation.

Preferred Qualifications:

• Experience with point-of-care or in-vitro diagnostic devices.

Job 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 existing behavior, architecture, dependencies, and technical limitations.
• Resolve complex software, firmware, hardware-integration, performance, reliability, and field issues.
• Translate system and product requirements into clear, testable software requirements and technical designs.
• Decompose system-level requirements into embedded software components and interfaces.
• Ensure alignment between software requirements, architecture, detailed design, implementation, risk controls, and verification evidence.
• Participate in and lead technical reviews, software design reviews, code reviews, and root-cause investigations.
• Collaborate with electrical and systems engineers on hardware-software interfaces, sensors, communication protocols, diagnostics, and device behavior.
• Develop low-level drivers, device-control logic, hardware abstraction layers, communication components, and application-level embedded functionality.
• Support integration between embedded devices and external systems such as middleware, host applications, hospital networks, or cloud services.
• Perform technical impact analysis for software changes, defects, anomalies, component updates, and cybersecurity vulnerabilities.
• Support software remediation by identifying gaps between documented requirements and implemented behavior.
• Create or update software lifecycle documentation required for the Design History File.
• Ensure complete bidirectional traceability between requirements, risks, design, code, tests, defects, and release evidence.
• Collaborate with V&V and Software Quality teams to define verification approaches and improve testability.
• Support unit, integration, system, regression, performance, reliability, and cybersecurity testing.
• Investigate field-reported issues and support corrective and preventive actions.
• Support controlled software builds, releases, configuration management, and design changes.
• Contribute to product risk analysis and ensure that software-related risk controls are properly implemented and verified.
• Support internal audits, regulatory inspections, and submission-related activities.
• Mentor software engineers and promote effective embedded-development and documentation practices.
• Identify architectural improvements and technical-debt reduction opportunities.
• Drive continuous improvement of software engineering processes, tools, code quality, and development efficiency.

Department/Project Description

Project Overview

The customer is a global medical-device company developing point-of-care diagnostic systems used in hospitals and clinical environments.

The project supports the development, maintenance, and remediation of an established medical-device product line. The scope includes embedded software development, analysis of existing implementations, resolution of design and documentation gaps, product improvements, and support throughout the regulated medical-device lifecycle.

We are looking for a Principal-level Embedded Software Engineer who can provide hands-on technical leadership and solve complex system and software problems in a regulated environment.

Role Overview

• The Principal Medical Device Embedded Software Engineer will serve as a senior individual contributor responsible for the architecture, design, implementation, integration, and maintenance of embedded software for regulated medical devices.
• The role requires deep embedded-development expertise combined with practical knowledge of medical-device design controls, risk management, verification, traceability, and Design History File documentation.
• The engineer will work closely with Systems Engineering, Electrical Engineering, Software Quality Assurance, Verification and Validation, Regulatory Affairs, Manufacturing, and other cross-functional stakeholders.
• This is not a people-management position. The successful candidate will lead through technical ownership, architectural decision-making, mentoring, and cross-functional influence.