Systems Engineering Manager (Console System)

Systems Engineering Manager

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.

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The Systems Engineering Manager will lead the system integration, requirements execution, and end-to-end system development for Boston Scientific's intravascular lithotripsy (IVL) platform within the Interventional Cardiology and Vascular Therapies (ICVT) division. This role is critical to delivering a high-performance system integrating capital equipment (console/generator), software, and catheter-based disposable devices. You will oversee the console system development, including system integration, interface definition, and system-level testing to ensure reliable interaction between console and catheter subsystems. This position is highly execution-focused: driving system lifecycle activities from design through commercialization while leading a team of systems engineers and ensuring alignment with clinical, technical, and regulatory requirements.

This role is onsite, requiring employees to work from the local office in Carlsbad, CA to support hands-on system integration, test execution, and cross-functional collaboration.

Relocation assistance is not available for this position at this time.

Boston Scientific will not offer sponsorship or take over sponsorship of an employment visa for this position at this time.

Your responsibilities will include:

• Lead and develop a team of systems engineers responsible for system integration, system testing, and requirements execution
• Drive integration of the IVL system across console/generator hardware, embedded and application software, and catheter/disposable devices to ensure seamless system performance
• Define, manage, and maintain system interfaces (electrical, software, mechanical, laser/optical, and user interactions) between console and catheter subsystems
• Oversee execution of the full system development lifecycle, including design, integration, testing, deployment, and maintenance
• Manage system requirements development and traceability, ensuring alignment from user needs through design outputs and system-level verification and validation
• Plan and lead system-level testing, including development and execution of manual and automated system tests to validate overall system performance
• Identify, troubleshoot, and resolve complex system-level integration issues, driving root cause analysis and cross-functional corrective actions
• Partner with R&D, clinical, quality, and regulatory teams to translate clinical workflows into system-level functionality, performance requirements, and usability considerations
• Support regulatory activities by providing technical inputs to submissions (e.g., 510(k), PMA), design documentation, and responses to regulatory authority questions
• Ensure compliance with design control processes and applicable regulatory standards throughout system development
• Manage resources, schedules, and priorities to achieve integration milestones, program deliverables, and system performance targets
• Build strong collaboration across cross-functional and multi-site teams to enable effective integration and execution
• Recruit, coach, and develop employees and organizational talent
• Foster a diverse workplace that enables all participants to contribute to their full potential in pursuit of organizational objectives
• Develop, monitor and appropriately adjust the budget for department
• Travel up to ~10-25% to support integration, testing, and cross-site collaboration

Required qualifications:

• Bachelor's degree in Engineering or related technical discipline (or equivalent experience)
• 10+ years of experience in development, integration, and testing of complex systems, preferably medical devices
• 5+ years of experience leading engineering teams or technical functions in a regulated environment
• Demonstrated expertise in system integration, system-level testing, and cross-functional product development execution
• Experience developing and supporting Class II and/or Class III medical devices, including design control and documentation requirements
• Experience supporting regulatory activities, including contributing to submissions and responding to regulatory authority questions (e.g.: FDA)
• Experience with requirements management and issue tracking tools (e.g.: Jama, Jira)
• Working knowledge of medical device standards such as IEC 62304 and ISO 60601
• Proven ability to manage multiple projects and priorities in a fast-paced development environment

Preferred qualifications:

• Advanced degree (MS, MBA, or equivalent) in Engineering or related field
• Experience with developing capital medical devices
• Experience leading system-level verification and validation strategy and execution
• Familiarity with risk management processes and standards (e.g.: ISO 14971)
• Experience working across global or multi-site engineering teams
• Strong understanding of clinical workflows and translating user needs into system functionality

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