Boston Scientific is hiring an Embedded Software Engineer III to play a critical role in the evaluation, development, and integration of firmware for active implantable neuromodulation devices within the Urology division. You will contribute across the full product development lifecycle while collaborating with a cross-functional R&D team committed to safety, quality, and continuous improvement.
What You'll Do
- Participate in technology evaluations, technical specification development, and validation of firmware architectures and embedded software for active implantable medical devices.
- Support firmware architecture, detailed design, and real-time embedded development in alignment with IEC 62304 and applicable FDA regulations.
- Ensure compliance with ISO 13485, ISO 14971, FDA Quality System Regulation, and medical device cybersecurity standards, including FDA premarket cybersecurity guidance and IEC 62443.
- Identify and mitigate firmware-related risks, cybersecurity vulnerabilities, and system integration challenges, including those associated with acquired technologies.
- Collaborate with hardware, systems, risk management, regulatory affairs, and clinical teams to ensure seamless device integration and design execution.
- Develop and maintain comprehensive design documentation, traceability matrices, and software development lifecycle artifacts to support 510(k), PMA, and CE Mark submissions.
- Contribute to software and system risk management activities throughout the product development lifecycle.
- Develop and execute unit and integration test strategies and support design verification activities.
- Provide technical leadership in low-power embedded design, wireless communication technologies including BLE, NFC, and RF telemetry, and real-time operating system integration.
- Perform firmware testing, debugging, and verification using oscilloscopes, logic analyzers, hardware-in-the-loop simulations, and automated test environments.
- Establish and improve firmware development lifecycle processes aligned with Boston Scientific’s quality management system.
- Support product transfer from R&D to manufacturing and sustaining engineering.
- Foster innovation, continuous improvement, and knowledge sharing within the R&D engineering team.
What We're Looking For
- Bachelor’s degree in computer science, computer engineering, software engineering, electrical engineering, or a related field.
- Minimum of 3 years' experience in embedded firmware development.
- Minimum of 1 year's experience in implantable, Class III, or other regulated medical devices.
- Strong proficiency in C/C++ for microcontroller-based firmware development.
- Experience developing low-power embedded systems with and without real-time operating systems.
- Experience with firmware risk assessment, cybersecurity principles, and regulatory-compliant software development.
- Knowledge of PC-based application development using Microsoft Visual Studio.
- Strong communication, documentation, and organizational skills.
Nice to Have
- Working knowledge of ISO 13485, ISO 14971, and FDA Quality System Regulation requirements.
- Experience supporting mergers and acquisitions due diligence activities within the medical device industry.
- Hands-on experience with secure bootloaders, cryptographic protocols, and over-the-air firmware updates.
- Advanced expertise in Bluetooth Low Energy, including peripheral, central and dual roles, pairing, GATT profiles, security implementation, and custom services.
- Experience working with BLE software stacks such as Nordic or Onsemi and optimizing for ultra-low-power and performance-constrained environments.
Technical Stack
- C/C++
- Microsoft Visual Studio
- BLE, NFC, RF telemetry
- Nordic BLE stack, Onsemi BLE stack
Team & Environment
You will join a cross-functional R&D team within the Urology division, collaborating with hardware, systems, risk management, regulatory affairs, and clinical teams.
Benefits & Compensation
- Compensation range: $78,300 - $148,800
Work Mode
This is a hybrid position located in US-MN-Arden Hills or US-MN-Maple Grove.
Boston Scientific is an equal opportunity employer, committed to diversity, innovation, caring, global collaboration, a winning spirit, and high performance.
