Principal Systems Engineer

Boston Scientific • Irvine, CA

3d • Hybrid

About The Position

Boston Scientific was recognized by Forbes as one of the Best Workplaces for Engineers in 2026, reflecting a culture where engineers do meaningful work. We are seeking an experienced Principal Systems Engineer to join the Urology team. In this role, you will provide technical leadership in the development of complex medical device systems, including active implantables, capital equipment and software-based products, from concept through product launch. You will also support acquisition and integration activities, providing technical expertise in system evaluation, integration planning and execution. This role requires strong systems thinking to balance business objectives, user needs and technical requirements while driving innovation and product performance across Urology franchises. At Boston Scientific, we value collaboration and synergy. This role follows a hybrid work model requiring employees to be in our local office at least three days per week. Boston Scientific will not offer sponsorship or take over sponsorship of an employment visa for this position at this time. Relocation assistance is not available for this position at this time.

Requirements

• Bachelor’s or master’s degree in electrical engineering, computer science, biomedical engineering or a related field
• 8+ years' experience in product development, preferably in a regulated environment
• Experience with requirements development, system design, trade-off analysis, integration, risk management and verification and validation processes
• Strong knowledge of design controls and risk management practices
• Proficiency in technical documentation, design controls and quality system processes
• Knowledge of software and system architecture principles
• Experience using configuration management, test management, requirements management, and issue tracking systems.
• Demonstrated ability to lead teams in solving complex technical problems
• Strong communication skills and ability to influence cross-functional stakeholders
• Ability to collaborate effectively across functions and communicate technical insights clearly

Nice To Haves

• 5+ years' experience leading product development teams in a regulated medical device environment
• Experience developing system requirements and architecture for implantable devices and connected platform ecosystems
• Knowledge of human factors and usability engineering processes
• Experience interacting with regulatory bodies such as FDA, BSI or TÜV
• Experience in program or project management and/or PMP certification

Responsibilities

• Lead systems engineering efforts for complex medical device platforms, including active implantables, capital systems and software-only products, to drive innovation and market differentiation
• Support acquisition and integration activities, including technical due diligence, technology evaluations, gap assessments and integration planning in collaboration with cross-functional teams
• Translate user needs and business requirements into comprehensive system requirements, including hardware, software, mechanical, electrical and interface specifications
• Define and support system architecture, design and integration of next-generation technologies in alignment with Boston Scientific quality systems
• Apply systems thinking to evaluate system and subsystem interactions and assess the impact of design changes across the full product ecosystem
• Identify technical risks, develop mitigation strategies and execute phased integration and characterization plans to reduce risk
• Analyze system requirements for completeness and testability; support system verification and validation, test method development and traceability
• Contribute to risk management activities, including use and design FMEAs
• Support concept development, system design and functional prototyping of products and interfaces
• Act as an R&D representative on cross-functional teams, collaborating with quality, regulatory and project management stakeholders
• Develop and maintain documentation in compliance with the product development process and quality management system
• Drive project planning, tracking and issue resolution while communicating progress and recommendations to senior leadership
• Champion engineering best practices and lead problem-solving efforts across functions to address complex technical challenges
• Mentor and develop engineers, building systems engineering capability and supporting knowledge sharing across the organization
• Continuously improve processes and methodologies using agile and lean principles to enhance efficiency and solve interdisciplinary challenges

Benefits

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

What This Job Offers

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