Senior Software Engineer
Senior Embedded Software Engineer - Medical Devices
Location: United States | Hybrid in Duluth, GA or Fully Remote on the East Coast
Industry: Medical Devices
Employment Type: Full-Time
Compensation: $170,000-$200,000 Base + Annual Bonus + Equity
About the Role
A fast-growing, mission-driven medical device company is seeking a Senior Embedded Software Engineer to lead the development of embedded software for next-generation regulated medical devices. This is a high-impact role for an engineer who enjoys working across software, hardware, product, quality, and clinical teams to build reliable products that directly improve patient outcomes.
In this position, you will design, develop, and maintain embedded software that interfaces with electromechanical systems, sensors, optical technologies, and real-time data acquisition platforms. You will play a key role in software architecture, algorithm development, regulatory documentation, cybersecurity readiness, verification, and overall product development within a regulated medical device environment.
Key Responsibilities
- Design, develop, test, and maintain high-performance embedded software for regulated medical device or scientific instrumentation systems.
- Develop clean, well-documented C++ code for Linux-based embedded platforms, including Yocto or similar environments.
- Build and optimize algorithms related to signal processing, spectral analysis, sensor integration, device control, and real-time data acquisition.
- Lead software architecture discussions, design reviews, code reviews, debugging efforts, and technical decision-making.
- Integrate software with electrical, mechanical, optical, sensor, and spectrometry-based subsystems.
- Create and maintain software documentation, including requirements, architecture, design specifications, verification plans, test protocols, and traceability matrices.
- Support compliance with medical device standards and quality systems, including IEC 62304, ISO 13485, FDA 21 CFR Part 820, and FDA QSR requirements.
- Manage version-controlled software repositories using Git or similar tools to support collaboration, traceability, and release control.
- Contribute to cybersecurity activities, including threat modeling, software bill of materials management, vulnerability assessments, and risk documentation aligned with FDA guidance.
- Collaborate with product, quality, regulatory, hardware, clinical, and external development partners to translate user needs into safe, reliable software solutions.
- Support verification and validation activities, including unit testing, integration testing, system testing, root-cause analysis, and product improvements.
- Stay current with emerging embedded software, cybersecurity, and medical device development practices and recommend improvements to tools, processes, and product architecture.
Qualifications
- Bachelor's or Master's degree in Computer Science, Electrical Engineering, Biomedical Engineering, Computer Engineering, or a related technical discipline.
- 5+ years of embedded software development experience within medical devices, scientific instrumentation, diagnostic equipment, robotics, imaging systems, or other regulated hardware-integrated products.
- Strong experience developing embedded software in C++ on Linux-based platforms, ideally including Yocto or comparable embedded Linux environments.
- Strong background in algorithm development, signal processing, real-time data acquisition, sensor integration, and embedded system design.
- Experience working within regulated product development environments and familiarity with IEC 62304, ISO 13485, FDA QSR, and FDA 21 CFR Part 820.
- Proven ability to produce clear technical documentation for software requirements, architecture, design, verification, validation, and traceability.
- Experience managing or contributing to SBOMs, cybersecurity risk assessments, vulnerability management, or threat modeling.
- Strong debugging, problem-solving, and root-cause analysis skills across software and hardware-integrated systems.
- Excellent communication skills with the ability to work effectively across software, hardware, quality, regulatory, product, and clinical teams.
Preferred Experience
- Experience with optical sensors, spectrometers, imaging systems, spectroscopy, or other optical measurement technologies.
- Prior involvement in FDA submissions, CE marking, design history files, technical files, or regulated product launches.
- Experience coordinating with external development partners, contract manufacturers, or third-party software teams.
- Familiarity with software lifecycle processes, risk management, and cybersecurity expectations for connected medical devices.
FAQs
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