Embedded Software Engineer

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.