Senior Embedded Software Engineer

Innovation - Diversity - 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.         

 

 

Senior Embedded Software Engineer  - Axonics/Boston Scientific Urology Products

Irvine, CA (Onsite)

 

About the Role:

As Senior Embedded Software Engineer, you will be part of the evaluation, and integration of firmware technologies for active implantable medical devices. As a hands-on contributor, you will develop firmware for implantable devices, ensuring compliance with medical device regulations. You will use your deep expertise in embedded systems, system integration, real-time firmware development, and regulatory-compliant medical device firmware development.

 

Key Responsibilities 

 

•         Participate in technology evaluations, technical specification development, technical assessments and validation of firmware architectures, embedded software, and system integration aspects of active implantable medical devices.
•         Support the firmware specification development, firmware architecture, embedded firmware development, and integration for active implantable medical devices.
•         Ensure that firmware development aligns with IEC 62304, FDA, ISO 13485, ISO 14971and other regulatory standards governing medical device firmware.
•          Participate in Identifying potential risks, cybersecurity vulnerabilities, and integration challenges in acquired technologies. Ensure acquired firmware meets medical device cybersecurity and safety standards, including FDA premarket cybersecurity guidance, IEC 62443.
•          Collaborate with cross-functional teams, including hardware engineers, systems engineers, risk management, regulatory affairs, and clinical teams, to ensure seamless device integration.
•         Maintain thorough design documentation, traceability matrices, and software development lifecycle (SDLC) artifacts for regulatory submissions.
•         Participate in software and system risk management activities throughout the SDLC.
•         Participate in testing strategies (Unit/Integration) and design verification protocols to verify firmware functionality.
•         Provide technical inputs on low-power embedded systems, wireless communication (e.g., BLE, NFC, RF telemetry), and real-time operating systems (RTOS).
•         Establish and document firmware development lifecycle (SDLC) artifacts and processes to align with internal quality management systems (QMS).
•         Perform firmware testing, debugging, and verification efforts using tools such as unit testing frameworks, hardware-in-the-loop (HIL) simulations, and automated test environments.
•         Collaborate with regulatory teams on 510(k), PMA, or CE Mark submissions involving firmware-related changes.
•         Contributes to the process of transferring the product from development to manufacturing.
•         Foster a culture of innovation, continuous improvement, and knowledge sharing within the R&D team.

 

Minimum Required Qualifications

 

• Bachelor’s degree or higher in Computer Science, Computer Engineering, Software Engineering, Electrical Engineering, or related major
• 4+ years of experience in embedded firmware development
• 2+ years in implantable or Class III medical devices.
• Strong C/C++ skills for programming microcontroller systems.
• Expertise in low-power embedde