Principal Embedded Software Engineer

Halian | Managed Services, Recruitment Agency & Contract Staffing; Waltham (MA); On-site; USD 180,000 - 240,000; Full time

Job summary

Halian is seeking a Principal Embedded Software Engineer to lead architecture and development for regulated medical devices. You will own embedded C/C++ design, collaborate across engineering, quality and regulatory teams, and mentor others while ensuring IEC 62304 compliance and robust lifecycle documentation.

We expect extensive experience with Embedded Linux/RTOS, device drivers, and cross-functional execution.

Qualifications

• Extensive embedded software/firmware experience in regulated environments.
• Hands-on leadership with architecture, design, and code reviews in medical devices.
• Strong knowledge of IEC 62304 lifecycle processes and design controls.

Responsibilities

• Lead architecture, design, development, debugging, and maintenance of embedded software for regulated devices.
• Develop high-quality embedded apps in C/C++ with RTOS and Embedded Linux.
• Define and improve software architecture, interfaces, and HALs.
• Modernize legacy code and drive hardware-software integration.
• Create and review software lifecycle documentation and DHF artifacts.
• Mentor engineers and collaborate with quality/regulatory teams.

Skills

Embedded C/C++

Technical leadership

Mentoring

Embedded debugging

Architectural ownership

Cross-functional collaboration

RTOS/Embedded Linux

Device drivers

Education

Bachelor's or Master's degree in engineering

Tools

JTAG

Oscilloscopes

Logic analyzers

CI/CD pipelines

Job description

We're looking for a Principal Embedded Software Engineer with extensive experience developing embedded software for regulated medical devices.

This is a hands-on technical leadership role for someone who understands both the complexities of embedded systems and the discipline required to develop software in a regulated environment.

You'll work on an established medical-device product line, contributing to software architecture, embedded C/C++ development, legacy code analysis, system integration, and software remediation.

A significant part of the role involves ensuring that existing and new software meets medical-device development standards, including IEC 62304, ISO 14971, FDA Design Controls, and software lifecycle traceability requirements.

This is not a people-management position. You'll lead through technical expertise, architectural ownership, mentoring, and collaboration with engineering, quality, and regulatory teams.

About the Client

Our client is an established medical technology company developing diagnostic systems used in hospitals and clinical environments.

Its engineering teams support the development, maintenance, and continuous improvement of regulated medical devices, combining embedded software engineering, hardware integration, product safety, and regulatory compliance.

What You'll Do

• Lead the architecture, design, development, debugging, and maintenance of embedded software and firmware for regulated medical devices.
• Develop high-quality embedded applications using C and/or C++, including multithreaded, real-time, and event-driven software.
• Define and improve embedded software architecture, component interfaces, hardware abstraction layers, and communication mechanisms.
• Analyze and modernize legacy embedded codebases, identifying technical limitations, design gaps, and opportunities for improvement.
• Develop device drivers, hardware interfaces, diagnostic functions, and communication components.
• Work with Embedded Linux, RTOS, and low-level hardware interfaces to support reliable device operation.
• Troubleshoot complex software, firmware, hardware integration, timing, memory, performance, and field-reported issues.
• Collaborate with Systems Engineering, Electrical Engineering, Software Quality, Verification and Validation, and Regulatory Affairs teams.
• Translate system-level requirements into detailed, testable embedded software requirements and technical designs.
• Ensure software development activities follow IEC 62304 lifecycle processes and applicable quality management requirements.
• Support software risk assessments, hazard analysis, risk-control implementation, and verification.
• Establish and maintain bidirectional traceability between requirements, architecture, risks, implementation, testing, and release documentation.
• Create, review, and remediate software lifecycle documentation supporting the Design History File (DHF).
• Participate in technical design reviews, code reviews, root-cause investigations, and corrective action activities.
• Support software verification, validation, regulatory submissions, audits, and inspections.
• Mentor engineers and promote effective embedded software development, documentation, and testing practices.

What We're Looking For

• 10–15+ years of professional embedded software or firmware development experience, including demonstrated Principal Engineer, Senior Staff Engineer, or equivalent technical leadership responsibilities.
• Bachelor's or Master's degree in Computer Science, Computer Engineering, Electrical Engineering, Software Engineering, Biomedical Engineering, or a related discipline.
• Advanced hands-on programming experience with Embedded C and/or C++.
• Strong understanding of the complete embedded software lifecycle, from requirements and architecture through implementation, verification, release, and maintenance.
• Experience developing software using Embedded Linux and/or Real-Time Operating Systems (RTOS).
• Strong understanding of multithreading, concurrency, state machines, memory management, fault handling, and real‑time system design.
• Experience with low‑level firmware, device drivers, hardware abstraction, board bring‑up, and hardware-software integration.
• Knowledge of communication protocols such as UART, SPI, I²C, USB, CAN, and Ethernet.
• Experience debugging embedded systems using JTAG, oscilloscopes, logic analyzers, protocol analyzers, or similar tools.
• Experience analyzing, troubleshooting, and improving large or legacy embedded software codebases.
• Practical understanding of medical-device software development standards, design controls, risk management, and traceability.
• Experience producing controlled technical documentation, software design records, verification evidence, and release documentation.
• Strong analytical, troubleshooting, and root‑cause analysis skills.
• Ability to lead technical initiatives and influence engineering decisions without direct management authority.

Preferred Qualifications

• Strong working knowledge of IEC 62304, ISO 13485, ISO 14971, and FDA Design Controls.
• Familiarity with FDA 21 CFR Part 820, IEC 62366-1, EU MDR, or IVDR requirements.
• Experience supporting Design History File remediation, regulatory submissions, or medical-device audits.
• Experience with software verification and validation, static analysis, code coverage, and automated testing.
• Familiarity with embedded cybersecurity, secure software development, vulnerability assessments, and FDA cybersecurity guidance.
• Experience with cross‑compilation toolchains, controlled builds, CI/CD pipelines, and configuration management.
• Exposure to device connectivity, hospital networks, middleware integration, or cloud‑connected medical devices.
• Experience supporting sustaining engineering, field issue investigations, and corrective and preventive actions (CAPA).

Why Consider This Role?

• Principal‑level technical ownership: Influence embedded software architecture and engineering decisions while remaining hands‑on with development.
• Meaningful engineering challenges: Work on complex embedded systems involving software, hardware, reliability, and regulatory requirements.
• Established medical‑device products: Contribute to product improvements, legacy software remediation, and long‑term software maintainability.
• Cross‑functional collaboration: Work closely with engineering, quality, regulatory, and verification teams.
• Technical leadership without people management: Mentor engineers, lead technical reviews, and shape engineering practices without direct management responsibilities.