Principal Systems Engineer (Console System)

Boston Scientific • Arden Hills, MN

6d • $106,800 - $202,900 • Onsite

About The Position

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.

Requirements

• Bachelor's degree in Engineering or related technical discipline (or equivalent experience).
• 7+ years of engineering experience involving technology development, product development, or complex system development activities.
• 5+ years of technical leadership experience on cross-functional engineering teams.
• 5+ years of experience in systems engineering of multidisciplinary products involving hardware and software integration.
• Demonstrated expertise in requirements development, systems architecture, interface management, verification, validation, and traceability.
• Experience developing and supporting Class II and/or Class III medical devices.
• Experience working within regulated development environments utilizing Design Controls and quality system requirements.
• Familiarity with engineering change orders (ECOs), CAPAs, requirements management, and technical documentation.
• Experience with requirements management tools such as Jama, DOORS, Requisite Pro, Jira, or similar platforms.
• Strong analytical, systems-thinking, and problem-solving capabilities.
• Excellent written and verbal communication skills with the ability to communicate complex technical concepts across diverse audiences.
• Proven ability to lead technical discussions, influence design decisions, and drive cross-functional alignment.

Nice To Haves

• Advanced degree (MS or equivalent) in Systems Engineering, Electrical Engineering, Biomedical Engineering, Mechanical Engineering, Software Engineering, or related discipline.
• Experience developing capital medical equipment and disposable catheter-based therapies as an integrated medical device system.
• Experience supporting PMA and/or 510(k) submissions.
• Knowledge of medical electrical standards such as IEC 60601.
• Familiarity with communication protocols such as Ethernet, RS232, SPI, I2C, CAN, or similar technologies.
• Experience with MATLAB, Python, LabVIEW, Minitab, or similar analysis and modeling tools.
• Experience developing system models, simulations, algorithms, and feasibility studies.
• Experience with Agile product development methodologies.
• Experience integrating software, electrical, mechanical, optical, and disposable device technologies into a unified medical device platform.
• Familiarity with risk management methodologies and standards such as ISO 14971.
• Experience working across global or multi-site engineering teams.

Responsibilities

• 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 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.

What This Job Offers

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