Boston Scientific Senior Embedded Software Engineer - R&D 

United States, California, Irvine 

252215814

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

Maximum Salary: $ 164500

Compensation fornon-exempt (hourly), non-sales rolesmay also include variable compensation from time to time (e.g., any overtime and shift differential) and annual bonus target (subject to plan eligibility and other requirements).

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

For MA positions: It is unlawful to require or administer a lie detector test for employment. Violators are subject to criminal penalties and civil liability.

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.