Senior Embedded Software Engineer - R&D

Additional Location(s):  N/A

Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance

At Boston Scientific, we’ll give you the opportunity to harness all that’s within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges. With access to the latest tools, information and training, we’ll help you in advancing your skills and career. Here, you’ll be supported in progressing – whatever your ambitions. 

 

About the role:

At Boston Scientific, we transform patient care through meaningful innovation. As a Senior Embedded Software Engineer within our Urology division (Axonics), you’ll play a critical role in developing firmware for implantable neuromodulation devices that restore control and dignity to patients worldwide.

This hands-on role combines deep expertise in embedded systems with a strong commitment to safety, compliance, and performance in Class III medical devices. You’ll be involved in the full development cycle—designing, integrating, and validating real-time firmware—alongside a collaborative R&D team that values quality, innovation, and continuous improvement.

Join a mission-driven organization pioneering life-changing technologies in urologic health, and help shape the future of patient care.

 

Work mode:
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

Required qualifications:

• 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
   

Preferred qualifications:

• 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

 

Requisition ID: 613539 

Minimum Salary: $ 86600 

Maximum Sala