Boston Scientific
Senior Embedded Software Engineer - R&D
Boston Scientific, Irvine, California, United States, 92713
Overview
Additional Location(s): N/A
Diversity - Innovation - 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.
About the role 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 cycle—designing, integrating, and validating real-time firmware—alongside 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.
Work mode At Boston Scientific, we value collaboration and synergy. This particular role follows a hybrid work model, requiring employees to be present at our Irvine, California office 3 days per week.
Visa sponsorship Boston Scientific will not offer sponsorship or take over sponsorship of an employment visa for this position at this time.
Your responsibilities
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
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
Requisition ID 613539
Salary Minimum Salary: $86,600
Maximum Salary: $164,500
The anticipated compensation listed above and the value of core and optional employee benefits offered by Boston Scientific (BSC) - see www.bscbenefitsconnect.com - will vary based on actual location of the position and other pertinent factors considered in determining actual compensation for the role. Compensation will be commensurate with demonstrable level of experience and training, pertinent education including licensure and certifications, among other relevant business or organizational needs. At BSC, it is not typical for an individual to be hired near the bottom or top of the anticipated salary range listed above.
Compensation for non-exempt (hourly), non-sales roles may 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 for exempt, non-sales roles may 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.
Equal opportunity statement Boston Scientific is an equal opportunity employer. We stand for inclusion, equality, and opportunity for all. By embracing the richness of our unique backgrounds and perspectives, we create a better, more rewarding place for our employees to work and reflect the patients, customers, and communities we serve.
Boston Scientific Corporation has been and will continue to be an equal opportunity employer. Recruitment, hiring, assignment, promotion, compensation, and all other personnel decisions are made without regard to race, religion, color, national origin, citizenship, sex, sexual orientation, gender identity, gender expression, veteran status, age, mental or physical disability, genetic information or any other protected class.
Please be advised that certain US based positions require acceptable proof of COVID-19 vaccination status. Candidates will be notified during the interview and selection process if the role requires 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.
Among other requirements, Boston Scientific maintains specific prohibited substance test requirements for safety-sensitive positions. This role is deemed safety-sensitive and candidates will be subject to a prohibited substance test as a requirement.
#LI-Hybrid
#J-18808-Ljbffr
Diversity - Innovation - 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.
About the role 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 cycle—designing, integrating, and validating real-time firmware—alongside 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.
Work mode At Boston Scientific, we value collaboration and synergy. This particular role follows a hybrid work model, requiring employees to be present at our Irvine, California office 3 days per week.
Visa sponsorship Boston Scientific will not offer sponsorship or take over sponsorship of an employment visa for this position at this time.
Your responsibilities
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
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
Requisition ID 613539
Salary Minimum Salary: $86,600
Maximum Salary: $164,500
The anticipated compensation listed above and the value of core and optional employee benefits offered by Boston Scientific (BSC) - see www.bscbenefitsconnect.com - will vary based on actual location of the position and other pertinent factors considered in determining actual compensation for the role. Compensation will be commensurate with demonstrable level of experience and training, pertinent education including licensure and certifications, among other relevant business or organizational needs. At BSC, it is not typical for an individual to be hired near the bottom or top of the anticipated salary range listed above.
Compensation for non-exempt (hourly), non-sales roles may 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 for exempt, non-sales roles may 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.
Equal opportunity statement Boston Scientific is an equal opportunity employer. We stand for inclusion, equality, and opportunity for all. By embracing the richness of our unique backgrounds and perspectives, we create a better, more rewarding place for our employees to work and reflect the patients, customers, and communities we serve.
Boston Scientific Corporation has been and will continue to be an equal opportunity employer. Recruitment, hiring, assignment, promotion, compensation, and all other personnel decisions are made without regard to race, religion, color, national origin, citizenship, sex, sexual orientation, gender identity, gender expression, veteran status, age, mental or physical disability, genetic information or any other protected class.
Please be advised that certain US based positions require acceptable proof of COVID-19 vaccination status. Candidates will be notified during the interview and selection process if the role requires 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.
Among other requirements, Boston Scientific maintains specific prohibited substance test requirements for safety-sensitive positions. This role is deemed safety-sensitive and candidates will be subject to a prohibited substance test as a requirement.
#LI-Hybrid
#J-18808-Ljbffr