Boston Scientific Principal Software Engineer - Urology R&D Mobile Applications 

United States, California, Irvine 

137685994

About the Role:

We are seeking a Principal Software Engineer to lead the development of mobile applications that interface with our sacral neuromodulation medical devices. As both a technical leader and hands-on contributor, you will work across the full software development lifecycle while ensuring compliance with medical device regulatory standards. This role requires deep expertise in application software development, integration with low-power embedded systems including neurostimulators, cross-platform mobile development for Android and iOS, automated test frameworks, and compliant software engineering within regulated medical environments.

Your responsibilities will include:

• Support software architecture, design, development, testing strategies, and risk management activities for mobile medical software applications.
• Lead the full design life cycle process, including requirements specification, design planning, code reviews, and creation of corresponding artifacts.
• Ensure compliance with IEC 62304, FDA regulations, ISO 13485, ISO 14971, and other applicable medical device standards throughout software and firmware development.
• Contribute to mobile application prototyping and user interface development efforts.
• Develop and implement unit and integration testing strategies, as well as design verification protocols.
• Execute software testing, debugging, static analysis, cybersecurity assessments, and verification using tools such as unit testing frameworks, hardware-in-the-loop (HIL) simulations, and automated test environments.
• Provide technical leadership in software design and apply industry best practices for high-quality, maintainable code.
• Promote collaboration, pragmatic decision-making, and cross-functional alignment throughout the development process.
• Ensure compliance with medical device cybersecurity and safety standards, including FDA premarket cybersecurity guidance and IEC 62443.
• Collaborate with hardware and firmware engineers, systems engineers, quality assurance, regulatory affairs, manufacturing, and program management teams to ensure seamless integration.
• Establish and document software development lifecycle (SDLC) artifacts and processes in alignment with internal quality management systems (QMS). Maintain thorough design documentation and traceability matrices to support regulatory submissions.
• Mentor software engineers by guiding best practices in architecture, implementation, and documentation.
• Support regulatory submissions such as 510(k), PMA, or CE Mark by collaborating with quality and regulatory teams.
• Foster a culture of innovation, continuous improvement, and knowledge sharing within the R&D organization.

Required qualifications:

• Bachelor’s degree or higher in Computer Science, Electrical Engineering, Computer Engineering, Software Engineering, or a related technical field.
• Minimum of 5 years of relevant software development experience, or 4 years with an advanced degree in a related discipline.
• At least 3 years of experience developing embedded or application software, preferably in the medical device or other regulated industries.
• Strong understanding of software engineering principles, including object-oriented programming and API design.
• Proficiency in one or more programming languages such as Swift, Java, Dart, C#, or Objective-C.
• Experience with mobile operating systems and platforms, including iOS and Android.
• Familiarity with cross-platform mobile application development frameworks.
• Experience working in regulated environments such as those governed by the FDA is strongly preferred.
• Demonstrated project management and communication skills.
• Ability to work effectively in a collaborative team environment.

Preferred qualifications:

• Knowledge of UI/UX design principles is a plus.
• Experience in cloud backend development and API interfacing with mobile applications.
• Familiarity with risk assessment, cybersecurity principles, and regulatory compliance practices for implantable medical devices and related software systems.
• In-depth knowledge of Bluetooth Low Energy (BLE) stacks and BLE APIs on major mobile platforms.
• Experience integrating BLE-enabled embedded systems with applications on iOS, Android, and Windows.
• Proficiency in PC application development using Microsoft Visual Studio (e.g., C#.NET).
• Practical experience with secure bootloaders, cryptographic protocols, and over-the-air firmware update mechanisms for embedded or implantable devices.

Maximum Salary: $ 197000

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.