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Senior Embedded Software Engineer - Urology R&D

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 cycledesigning, integrating, and validating real-time firmwarealongside 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. 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