Principal Systems Engineer; Console System

Principal Systems Engineer

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.

The Principal Systems Engineer will provide technical leadership for the development, integration, and commercialization of Boston Scientific's next-generation Intravascular Lithotripsy (IVL) platform within the Interventional Cardiology and Vascular Therapies (ICVT) division. This role is responsible for driving system architecture, requirements development, integration strategy, system verification, and cross-functional execution across a complex medical device ecosystem consisting of capital equipment (console/generator), embedded and application software, laser and optical subsystems, and catheter-based disposable devices.

As a senior technical contributor, you will serve as a key technical leader responsible for translating clinical and user needs into system-level requirements, interfaces, architectures, and verification strategies. You will drive technical decisions across hardware, software, mechanical, electrical, optical, and disposable subsystems while ensuring system performance, usability, reliability, safety, and regulatory compliance. You will work closely with engineering, quality, regulatory, clinical, manufacturing, and program management teams to deliver innovative Class II and Class III medical devices from concept through commercialization.

This role requires a deep understanding of engineering principles, medical device development, electromechanical systems, design controls, and the interface between reusable capital equipment and single-use disposable devices. The ideal candidate will possess strong analytical capabilities, hands-on development experience, and the ability to influence technical direction across multiple cross-functional teams.

• Serve as technical lead for complex system development activities supporting Boston Scientific's IVL platform, guiding system architecture, requirements, integration, and verification efforts.
• Define, develop, and maintain system requirements, system architecture, interface specifications, system performance requirements, and usability requirements.
• Lead requirements decomposition and traceability activities from user needs through subsystem requirements, design outputs, verification, and validation.
• Drive integration of the complete IVL system across console hardware, embedded software, application software, optical and laser subsystems, and catheter-based disposable devices.
• Define and manage interfaces between hardware, software, electrical, optical, mechanical, and disposable subsystems to ensure seamless system functionality and performance.
• Lead system-level trade studies, feasibility assessments, simulations, and modeling activities to evaluate design concepts and reduce program risk.
• Develop system performance characterization methods, measurement methodologies, acceptance criteria, and system-level test strategies.
• Plan, execute, and document integration testing, verification testing, validation testing, and system characterization activities.
• Conduct root cause analysis and drive resolution of complex technical issues spanning multiple engineering disciplines and subsystems.
• Collaborate with software, hardware, electrical, mechanical, optical, quality, regulatory, and clinical teams to ensure alignment with system requirements and development objectives.
• Lead technical reviews and provide guidance to cross-functional product and technology teams.
• Support project planning and technical risk management activities, identifying critical technical challenges early and driving mitigation actions.
• Develop and maintain system documentation, technical reports, engineering analyses, requirements specifications, interface documentation, and design documentation.
• Support Design Controls activities including risk management, engineering change orders (ECOs), CAPAs, requirements management, and design reviews.
• Contribute technical expertise to regulatory submissions, engineering justifications, responses to regulatory authority questions, and product lifecycle activities.
• Support compliance with applicable medical device standards and regulations, including electrical safety and system-level design considerations.
• Act as a technical mentor and provide guidance to engineers across disciplines while advancing systems engineering best practices across the organization.
• Build strong collaboration across cross-functional and multi-site teams to enable effective execution and successful product delivery.
• Travel up to approximately 10-20% to support development activities, testing, supplier interactions, and…