Boston Scientific Senior Embedded Software Engineer 

United States, California, Irvine 

259194648

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/wearable devices/or IoT devices.
• Strong C/C++ skills for programming microcontroller systems.
• Expertise in low-power embedded systems, programming for systems with or without real-time operating systems (RTOS), and microcontroller-based firmware development.
• Experience in firmware risk assessment, cybersecurity, and regulatory compliance for implantable devices.
• Experience using oscilloscopes, logic analyzers, and other related tools.
• Strong project management and communication skills.
• Detail-oriented and well organized.
• Experience in integrating BLE embedded systems with iOS, Android and Windows applications.
• Knowledge of PC application development in Microsoft Visual Studio (e.g. C#.Net).
• Hands-on experience with oscilloscopes, logic analyzers and other related tools.
• Willingness to work onsite at our Irvine, CA site

Preferred Qualifications:

• Knowledge of ISO 13485 and FDA QSR.
• Experience with mergers & acquisitions (M&A) due diligence in the medical device sector.
• Hands-on experience with secure bootloaders, cryptographic protocols, and over-the-air firmware updates for implantable devices.
• Expertise in BLE (Bluetooth Low Energy) in embedded systems including peripheral, central, dual roles, pairing, GATT profiles, security, custom services.
• Low level understanding of BLE software stacks (e.g. those from On Semi, Nordic) and experience in optimizing BLE software stack for performance constraints and ultra-low-power consumption constraints.

Base Salary Range

Minimum Salary: $ 86600

Maximum Salary: $ 164500

Compensation for
exempt, non-sales rolesmay also include variable compensation, i.e., annual bonus target and long-term incentives (subject to plan eligibility and other requirements).

Please be advised that certain US based positions, including without limitation field sales and service positions that call on hospitals and/or health care centers, require acceptable proof of COVID-19 vaccination status. Candidates will be notified during the interview and selection process if the role(s) for which they have applied require proof of vaccination as a condition of employment. Boston Scientific continues to evaluate its policies and protocols regarding the COVID-19 vaccine and will comply with all applicable state and federal law and healthcare credentialing requirements. As employees of the Company, you will be expected to meet the ongoing requirements for your roles, including any new requirements, should the Company’s policies or protocols change with regard to COVID-19 vaccination.

Among other requirements, Boston Scientific maintains specific prohibited substance test requirements for safety-sensitive positions. This role is deemed safety-sensitive and, as such, candidates will be subject to a prohibited substance test as a requirement. The goal of the prohibited substance testing is to increase workplace safety in compliance with the applicable law.