Embedded Software Engineer

Position Title:Embedded Software Engineer III

Location:Irvine, CA

Position Summary

We are seeking a highly skilledEmbedded Software Engineer IIIto join our R&D team focused onactive implantable medical devices. In this hands-on role, you will lead and contribute to thedevelopment, evaluation, and integrationof embedded firmware, ensuringregulatory complianceand 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 includingIEC 62304,FDA guidelines,ISO 13485, andISO 14971.

Cybersecurity & Risk Management

Identify and mitigate firmware-related risks, includingcybersecurity vulnerabilities.

Ensure firmware compliance withFDA premarket cybersecurity guidanceandIEC 62443.

Collaboration & Documentation

Work closely with hardware, systems, regulatory, clinical, and risk management teams.

Develop and maintaindesign documentation,traceability matrices, and otherSDLC artifactsto support regulatory submissions (e.g., 510(k), PMA, CE Mark).

Testing & Verification

Define and execute unit, integration, and system verification strategies.

Conduct firmware testing usingHIL simulations, automated environments, and debugging tools.

Lifecycle Management

Contribute toproduct transferfrom R&D to sustaining engineering.

Establish and document SDLC processes in accordance with the internalQMS.

Technical Contributions

Provide expertise inlow-power systems,wireless communication(BLE, NFC, RF telemetry), andRTOS-basedfirmware design.

Support continuous improvement, innovation, and knowledge sharing across engineering teams.

Required Qualifications

Bachelor's degree or higher inComputer Science,Computer Engineering,Electrical Engineering, or related field.

Minimum3 years of experienceinembedded firmware development.

At least1 year of experiencewithimplantable or Class III medical devices.

Proficiency inC/C++ programmingfor microcontroller-based systems.

Experience withRTOS,firmware architecture, andsystem integration.

Familiarity withmedical device cybersecurity,risk assessment, andregulatory compliance.

Proficient in using tools likeoscilloscopes,logic analyzers, andunit testing frameworks.

Strongproject management,documentation, andcommunication skills.

Experience integrating BLE-enabled embedded devices withiOS,Android, andWindowsplatforms.

Basic knowledge ofPC application developmentusing Microsoft Visual Studio (e.g., C#.NET).

Preferred Qualifications

Working knowledge ofISO 13485,FDA QSR, andmedical device design controls.

Experience withM&A due diligencein the medical technology sector.

Hands-on experience with:

Secure bootloaders,cryptographic protocols, andOTA firmware updates.

AdvancedBLE features: central/peripheral roles, GATT profiles, custom services, and BLE security.

Optimizing BLE stacksfrom vendors such asNordicorOn Semiconductorfor ultra-low power applications.