Job Description

Position Title: Embedded Software Engineer III

Location: Irvine, CA

Position Summary

We are seeking a highly skilled Embedded Software Engineer III to join our R&D team focused on active implantable medical devices . In this hands-on role, you will lead and contribute to the development, evaluation, and integration of embedded firmware, ensuring regulatory compliance and high-performance delivery for next-generation implantable technologies.

Key Responsibilities

• Technology Assessment & Integration
• Evaluate new firmware technologies and architectures for medical implants.
• Support system integration and technical assessments to ensure product compatibility.
• Firmware Development
• Design, develop, and integrate embedded firmware for active implantable medical devices.
• Align all firmware development with regulatory standards including IEC 62304 , FDA guidelines , ISO 13485 , and ISO 14971 .
• Cybersecurity & Risk Management
• Identify and mitigate firmware-related risks, including cybersecurity vulnerabilities .
• Ensure firmware compliance with FDA premarket cybersecurity guidance and IEC 62443 .
• Collaboration & Documentation
• Work closely with hardware, systems, regulatory, clinical, and risk management teams.
• Develop and maintain design documentation , traceability matrices , and other SDLC artifacts to support regulatory submissions (e.g., 510(k), PMA, CE Mark).
• Testing & Verification
• Define and execute unit, integration, and system verification strategies.
• Conduct firmware testing using HIL simulations , automated environments, and debugging tools.
• Lifecycle Management
• Contribute to product transfer from R&D to sustaining engineering.
• Establish and document SDLC processes in accordance with the internal QMS .
• Technical Contributions
• Provide expertise in low-power systems , wireless communication (BLE, NFC, RF telemetry), and RTOS-based firmware design.
• Support continuous improvement, innovation, and knowledge sharing across engineering teams.

Required Qualifications

• Bachelor's degree or higher in Computer Science , Computer Engineering , Electrical Engineering , or related field.
• Minimum 3 years of experience in embedded firmware development .
• At least 1 year of experience with implantable or Class III medical devices .
• Proficiency in C/C++ programming for microcontroller-based systems.
• Experience with RTOS , firmware architecture , and system integration .
• Familiarity with medical device cybersecurity , risk assessment , and regulatory compliance .
• Proficient in using tools like oscilloscopes , logic analyzers , and unit testing frameworks .
• Strong project management , documentation , and communication skills .
• Experience integrating BLE-enabled embedded devices with iOS , Android , and Windows platforms.
• Basic knowledge of PC application development using Microsoft Visual Studio (e.g., C#.NET).

Preferred Qualifications

• Working knowledge of ISO 13485 , FDA QSR , and medical device design controls .
• Experience with M&A due diligence in the medical technology sector.
• Hands-on experience with:
• Secure bootloaders , cryptographic protocols , and OTA firmware updates .
• Advanced BLE features : central/peripheral roles, GATT profiles, custom services, and BLE security.
• Optimizing BLE stacks from vendors such as Nordic or On Semiconductor for ultra-low power applications.

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