Principal Software Engineer - Urology R&D (Mobile Applications)

About the Role

Key Responsibilities

• 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.

Requirements

• 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.

Nice to Have

• 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.

Benefits & Perks

• The anticipated compensation listed above and the value of core and optional employee benefits offered by Boston Scientific will vary based on actual location and other factors.
• Compensation will be commensurate with experience and education.
• Variable compensation may include overtime, shift differentials, annual bonuses, and long-term incentives, depending on role and eligibility.