Systems Engineering Manager (Console System)

Boston Scientific • Carlsbad, CA

2d • $106,800 - $202,900 • Onsite

About The Position

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.

Requirements

• 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

Nice To Haves

• 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

Responsibilities

• 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

Benefits

• 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.
• core and optional employee benefits offered by Boston Scientific (BSC) – see www.bscbenefitsconnect.com

What This Job Offers

• Job Type: Full-time
• Career Level: Manager