Firmware Engineer

Firmware Engineer - Medical Devices (Embedded Systems)

Location: Irvine, CA (Hybrid / Onsite with some travel)

Job Type: Full-Time

Pay: $50 - $55 per hour

Position Overview

We are seeking an experienced Firmware Engineer to support the evaluation, integration, and compliance of embedded firmware for active implantable medical devices. This role plays a critical part in transitioning existing firmware into compliance while supporting ongoing development, validation, and regulatory submissions.

The ideal candidate has strong hands-on experience with embedded firmware development in C and C#, medical device software standards, and cross-functional collaboration within regulated environments.

Key Responsibilities

• Evaluate and assess firmware technologies and architectures for active implantable medical devices
• Support firmware requirements, architecture, development, and system integration activities
• Ensure firmware development complies with IEC 62304, FDA QSR, ISO 13485, ISO 14971, and related standards
• Collaborate with hardware, systems, risk management, regulatory, manufacturing, and clinical teams
• Develop and maintain design documentation, traceability matrices, and SDLC artifacts for regulatory submissions
• Participate in software and system risk management throughout the development lifecycle
• Define and execute unit, integration, and verification testing strategies
• Perform firmware testing and debugging using oscilloscopes, logic analyzers, HIL simulations, and automated test tools
• Provide technical input on low-power embedded systems and wireless technologies (BLE, NFC, RF telemetry)
• Support technology transfer from development to manufacturing
• Contribute to firmware-related activities supporting 510(k), PMA, and CE Mark submissions
• Help establish and improve firmware development processes aligned with internal QMS and SDLC standards
• Promote innovation, continuous improvement, and technical knowledge sharing within R&D

Required Qualifications

• Bachelor's degree or higher in Computer Science, Computer Engineering, Software Engineering, Electrical Engineering, or related field
  
  
  
  • Candidates with an MS degree and 2+ years of embedded firmware experience will be considered
  
  
  
  
• 4+ years of experience in embedded firmware development
• Strong proficiency in C and C# for microcontroller-based systems
• Experience with embedded firmware architecture and systems programming
• Experience with firmware risk assessment, cybersecurity, and regulatory compliance in medical devices
• Proficiency using oscilloscopes, logic analyzers, and related lab tools
• Experience developing PC-based applications using Microsoft Visual Studio / C#.NET
• Strong communication, organization, and project coordination skills
• Ability to work independently and manage multiple priorities

Preferred Qualifications

• Experience with active implantable medical devices (highly preferred)
• Knowledge of ISO 13485 and FDA Quality System Regulations (QSR)
• Expertise in low-power embedded system design
• Experience with wireless communication protocols (BLE, NFC, RF)

Work Environment

• Hybrid role with on-site work required in Irvine, CA
• Occasional travel to the Irvine site may be required
• Collaborative R&D and lab-based engineering environment

Employee Benefits

Medical, dental, vision, and pet insurance | 401(k) Retirement Savings Plans | Employee Assistance Program (EAP) | Commuter/Parking Accounts | People Perks | Health Savings Account (HSA) | AD & D Insurance

Apply Now

If you are a Firmware Engineer or Embedded Software Engineer with medical device experience and a passion for developing compliant, high-reliability systems, we encourage you to apply.

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