Systems Engineering ManagerAt 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.Boston Scientific was recognized by Forbes as one of the Best Workplaces for Engineers in 2026, reflecting a culture where engineers do meaningful work.Boston Scientific was recognized as a Glassdoor Best Place to Work in 2026, ranking No.
15 on the Top 100 list, reflecting the culture our employees experience every day.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 executionDrive integration of the IVL system across console/generator hardware, embedded and application software, and catheter/disposable devices to ensure seamless system performanceDefine, manage, and maintain system interfaces (electrical, software, mechanical, laser/optical, and user interactions) between console and catheter subsystemsOversee execution of the full system development lifecycle, including design, integration, testing, deployment, and maintenanceManage system requirements development and traceability, ensuring alignment from user needs through design outputs and system-level verification and validationPlan and lead system-level testing, including development and execution of manual and automated system tests to validate overall system performanceIdentify, troubleshoot, and resolve complex system-level integration issues, driving root cause analysis and cross-functional corrective actionsPartner with R&D, clinical, quality, and regulatory teams to translate clinical workflows into system-level functionality, performance requirements, and usability considerationsSupport regulatory activities by providing technical inputs to submissions (e.g., 510(k), PMA), design documentation, and responses to regulatory authority questionsEnsure compliance with design control processes and applicable regulatory standards throughout system developmentManage resources, schedules, and priorities to achieve integration milestones, program deliverables, and system performance targetsBuild strong collaboration across cross-functional and multi-site teams to enable effective integration and executionRecruit, coach, and develop employees and organizational talentFoster a diverse workplace that enables all participants to contribute to their full potential in pursuit of organizational objectivesDevelop, monitor and appropriately adjust the budget for departmentTravel up to ~10-25% to support integration, testing, and cross-site collaborationRequired 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 devices5+ years of experience leading engineering teams or technical functions in a regulated environmentDemonstrated expertise in system integration, system-level testing, and cross-functional product development executionExperience developing and supporting Class II and/or Class III medical devices, including design control and documentation requirementsExperience 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 60601Proven ability to manage multiple projects and priorities in a fast-paced development environmentPreferred qualifications:Advanced degree (MS, MBA, or equivalent) in Engineering or related fieldExperience with developing capital medical devicesExperience leading system-level verification and validation strategy and executionFamiliarity with risk management processes and standards (e.g.: ISO 14971)Experience working across global or multi-site engineering teamsStrong understanding of clinical workflows and translating user needs into system functionality