
Senior Embedded Software Engineer - R&D
- Irvine, CA
- $86,600 per year
- Permanent
- Full-time
At Boston Scientific, we value collaboration and synergy. This particular role follows a hybrid work model, requiring employees to be present at our Irvine, California office 3 days per week.Visa sponsorship:
Boston Scientific will not offer sponsorship or take over sponsorship of an employment visa for this position at this time.Your responsibilities will include:
- Participate in technology evaluations, specification development, and system integration of firmware for active implantable medical devices
- Support firmware architecture and embedded development, ensuring alignment with IEC 62304 and FDA regulations
- Identify potential risks, cybersecurity vulnerabilities, and integration challenges for acquired technologies
- Ensure compliance with FDA premarket cybersecurity guidance and IEC 62443 standards
- Collaborate with cross-functional teams including hardware, systems, risk management, regulatory, and clinical stakeholders
- Develop and maintain thorough documentation, traceability, and SDLC artifacts for regulatory submissions
- Participate in software and system risk management activities across the development lifecycle
- Develop and execute unit and integration tests, as well as design verification protocols
- Contribute to low-power embedded design, wireless communication (BLE, NFC, RF), and real-time OS integration
- Establish firmware development lifecycle processes in alignment with Boston Scientific’s QMS
- Conduct firmware testing, debugging, and verification using unit test frameworks and hardware-in-the-loop tools
- Support regulatory submissions (510(k), PMA, CE Mark) involving firmware changes
- Assist in the transfer of product designs from R&D to manufacturing
- Foster innovation and promote knowledge sharing within the R&D engineering team
- Bachelor’s degree or higher in Computer Science, Computer Engineering, Electrical Engineering, or related field
- 4+ years of experience in embedded firmware development
- 2+ years of experience with implantable, wearable, or IoT medical devices
- Proficiency in C/C++ for microcontroller-based firmware
- Strong knowledge of low-power embedded systems and RTOS development
- Experience with firmware risk assessment, cybersecurity, and regulatory compliance
- Skilled in using oscilloscopes, logic analyzers, and related test equipment
- Experience integrating BLE firmware with mobile (iOS/Android) and desktop (Windows) applications
- Familiarity with Microsoft Visual Studio and C#.Net
- Demonstrated communication, documentation, and organizational skills
- Working knowledge of ISO 13485, ISO 14971, and FDA QSR requirements
- Experience in M&A due diligence within the medical device sector
- Hands-on experience with secure bootloaders, cryptography, and OTA firmware updates
- Advanced BLE expertise, including pairing, security, GATT profiles, and custom services
- Experience with BLE stacks (e.g., Nordic, On Semi) and optimizing for low-power performance