Boston Scientific
Senior Embedded Software Engineer - R&D
Boston Scientific, Irvine, California, United States, 92713
Senior Embedded Software Engineer - R&D
Join to apply for the
Senior Embedded Software Engineer - R&D
role at
Boston Scientific
Additional Location(s): N/A
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 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 sectorHands‑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
Minimum Salary $86,600
Maximum Salary $164,500
Equal Opportunity Statement Boston Scientific Corporation has been and will continue to be an equal opportunity employer. To ensure full implementation of its equal employment policy, the Company will continue to take steps to assure that recruitment, hiring, assignment, promotion, compensation, and all other personnel decisions are made and administered without regard to race, religion, color, national origin, citizenship, sex, sexual orientation, gender identify, gender expression, veteran status, age, mental or physical disability, genetic information or any other protected class. We recognize that nurturing a diverse and inclusive workplace helps us be more innovative and it is important in our work of advancing science for life and improving patient health. That is why 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 continues to evaluate its policies regarding COVID‑19 vaccination requirements and will comply with all applicable state and federal law.
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.
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Senior Embedded Software Engineer - R&D
role at
Boston Scientific
Additional Location(s): N/A
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 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 sectorHands‑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
Minimum Salary $86,600
Maximum Salary $164,500
Equal Opportunity Statement Boston Scientific Corporation has been and will continue to be an equal opportunity employer. To ensure full implementation of its equal employment policy, the Company will continue to take steps to assure that recruitment, hiring, assignment, promotion, compensation, and all other personnel decisions are made and administered without regard to race, religion, color, national origin, citizenship, sex, sexual orientation, gender identify, gender expression, veteran status, age, mental or physical disability, genetic information or any other protected class. We recognize that nurturing a diverse and inclusive workplace helps us be more innovative and it is important in our work of advancing science for life and improving patient health. That is why 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 continues to evaluate its policies regarding COVID‑19 vaccination requirements and will comply with all applicable state and federal law.
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.
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