Senior Embedded Software Engineer

Innovation - Diversity - 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.         

Senior Embedded Software Engineer  - Axonics/Boston Scientific Urology Products

Irvine, CA (Onsite)

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.
• 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.

Requisition ID: 606223 

Base Salary Range

Minimum Salary: $ 86600 

Maximum Salary: $ 164500 

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 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).

As a leader in medical science for more than 40 years, we are committed to solving the challenges that matter most – united by a deep caring for human life. Our mission to advance science for life is about transforming lives through innovative medical solutions that improve patient lives, create value for our customers, and support our employees and the communities in which we operate. Now more than ever, we have a responsibility to apply those values to everything we do – as a global business and as a global corporate citizen.

So, choosing a career with Boston Scientific (NYSE: BSX) isn’t just business, it’s personal. And if you’re a natural problem-solver with the imagination, determination, and spirit to make a meaningful difference to people worldwide, we encourage you to apply and look forward to connecting with you!

At Boston Scientific, 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 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.

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.