Senior Staff Firmware Engineer — Waltham, MA

Note: J6BaUABu57F estimates the starting pay range for this role to be performed hybrid in Waltham, MA is $145,000 – $155,000 and reflects base salary only. This pay range is provided as a good faith estimate and the amount offered may be higher or lower. J6BaUABu57F takes many factors into consideration in making an offer, including candidate qualifications, work experience, operational needs, travel and onsite requirements, internal peer equity, prevailing wage, responsibilities, and other market and business considerations.

Role: Staff/Principal Embedded/Firmware Engineer (Medical Device)

Location: Waltham, MA (Hybrid)

Project Overview

Our client is a global medical-device company developing point-of-care diagnostic systems used in clinical environments. This project supports the development, maintenance, and remediation of an established product line. We are seeking a Principal-level Embedded Software Engineer who can provide hands-on technical leadership, solve complex system architecture problems, and navigate a strictly regulated medical-device lifecycle.

This is a senior individual contributor role requiring deep technical ownership, cross-functional collaboration, and the ability to engineer solutions at the lowest system levels.

Required Qualifications:

• Bachelor’s or Master’s degree in Computer Science, Computer/Electrical Engineering, or a related discipline.

• 10–15+ years of embedded software development experience, operating at a Principal Engineer, Software Architect, or equivalent level.

• Advanced Linux & Kernel Expertise: Deep, hands-on experience building custom Linux distributions, working directly in kernel mode, developing device drivers, and optimizing OS-level performance.

• Core Technical Skills: Expert-level C/C++, multithreaded/event-driven architectures, database integration, memory management, and hardware abstraction.

• Regulated Industry Experience: Proven background developing software for medical devices (IVD, healthcare products) or similar safety-critical regulated environments.

• Standards Proficiency: Strong working knowledge of IEC 62304, ISO 13485, ISO 14971, and FDA 21 CFR Part 820.

• Hardware/Debugging: Experience with hardware communication and debugging tools like oscilloscopes, logic analyzers, and JTAG.

• Excellent written and verbal English communication and technical documentation skills.

Key Responsibilities:

• Kernel & OS-Level Development: Build custom Linux OS distributions, execute system upgrades, and develop low-level drivers in kernel mode.

• Architectural Leadership: Define and evolve embedded software architecture, resolving complex challenges involving threading, concurrency, embedded databases, and hardware-software interfaces.

• Full-Lifecycle Engineering: Design, implement, debug, test, and maintain embedded software in C/C++ for safety-critical systems.

• Hardware Integration: Collaborate with electrical and systems engineers on board bring-up, sensor integration, diagnostics, and communication protocols (e.g., UART, SPI, I²C, USB).

• Medical Device Compliance: Ensure all development adheres to FDA Design Controls, IEC 62304, and ISO 13485. Translate system requirements into testable software designs, maintain strict traceability, and create required Design History File (DHF) documentation.

• Technical Remediation: Analyze legacy software to understand dependencies, resolve field issues, and drive technical-debt reduction and continuous process improvement.

What we offer

Exciting Projects:Come take your place at the forefront of digital transformation! With clients across all industries and sectors, we offer an opportunity to work on market-defining products using the latest technologies.

Collaborative Environment: You can expand your skills by collaborating with a diverse team of highly talented people in an open, laidback environment — or even abroad in one of our global centers or client facilities!

Work-Life Balance:J6BaUABu57F prioritizes work-life balance, which is why we offer flexible work schedules and opportunities to work from home.

Professional Development:We provide continuing education classes, professional certification and training (technical, soft skills, language, and communication skills) to help you realize your professional goals. Being part of a global organization, there are additional learning opportunities through international knowledge exchanges.

Excellent Benefits:We provide our employees with competitive salaries, health and life insurance, short-term and long-term disability insurance, a matched contribution 401K plan, flexible spending accounts, and PTO and holidays.

About J6BaUABu57F

J6BaUABu57F, a Hitachi Group Company, is a trusted digital engineering partner to the world’s largest and most forward-thinking companies. Since 2000, we’ve been at the forefront of the digital revolution – helping create some of the most innovative and widely used digital products and experiences. Today we continue to collaborate with clients in transforming businesses and redefining industries through intelligent products, platforms, and services.