Principal Systems Engineer - Urology R&D Boston Scientific's Urology team is looking for an experienced Principal Systems Engineer to help shape the future of complex medical device systems. This is a high-impact individual contributor role where you'll lead systems engineering efforts across both capital equipment and active implantable devices, from early concept through product launch. You'll be instrumental in supporting the acquisition and integration of active implantable systems, bringing your engineering expertise to technology evaluations and cross-functional planning. Your work will help ensure that technical solutions align with user needs, market opportunities, and business goals. In this role, you'll collaborate with teams across disciplines to turn business and technical requirements into smart, effective solutions. You'll also drive systems engineering activities across a diverse portfolio, including active implantables, capital systems, combination devices, and software-only products, fueling innovation and growth within the Urology franchise. Your responsibilities will include: Support acquisition and integration efforts for complex active implantable product systems, including due diligence activities such as technology evaluations, gap assessments, and remediation planning in collaboration with cross-functional teams Define and modify system requirements and designs to enable seamless integration of acquired product systems Translate user needs into system-level design requirements for new product development, including hardware, software, mechanical, electrical, and cloud components Develop comprehensive system and sub-system requirements, including security and interface specifications, to define the overall system architecture Architect and integrate new or next-generation technologies and products (implantable and capital platform ecosystems) in compliance with BSC quality systems, in partnership with technical and cross-functional stakeholders Apply systems thinking to define system and sub-system interactions and assess how product changes impact the broader system Identify and mitigate technical risks through risk burndown planning, phased integration strategies, and characterization studies Conduct special studies focused on improving system quality, usability, partitioning, and design trade-offs by researching and analyzing implementation options Analyze system requirements for testability and completeness, and support the development of system tests, characterization, test methods, and traceability documentation Contribute to system-level risk management activities, including Use and Design Failure Modes and Effects Analyses (FMEA) Design product features, generate concepts, and create functional prototypes for systems and related interfaces Represent R&D on cross-functional teams to support product development deliverables Create and maintain documentation aligned with the Product Development Process (PDP) and Quality Management System requirements Drive detailed project planning, progress tracking, and issue identification across engineering activities Collaborate with R&D, regulatory, quality, and project management teams on integration activities and communicate findings and recommendations to senior leadership and stakeholders Champion functional best practices and cross-functional problem-solving by engaging with internal and external experts to address complex challenges Mentor engineers to build systems engineering capabilities across engineering methodologies and domain-specific knowledge areas Improve cross-functional processes and methodologies using agile and lean principles to address complex, interdisciplinary challenges Required qualifications: Bachelor's degree in electrical engineering, computer science, biomedical engineering, or a related discipline Minimum of eight years of experience in product development activities, preferably within a regulated environment Experience in authoring requirements, system design, trade-off analysis, systems integration, risk management, and verification and validation (V&V) processes Proficiency in creating technical documentation and performing risk assessments and design control activities Understanding of software and system architectures, including associated design principles Experience working with configuration management, test management, requirements management, and issue tracking tools Demonstrated ability to lead teams using a structured, methodical approach to solving complex technical challenges Comprehensive knowledge of design controls and risk management practices Strong communication skills with the ability to build credibility across technical and non-technical audiences Proven ability to collaborate across functions and effectively communicate technical concepts and insights Preferred qualifications: Master's degree in electrical engineering, computer science, biomedical engineering, or a related discipline A minimum of five years of experience leading product development teams within a regulated medical environment Experience developing and modifying system architectures, system requirements, and system design for implantable medical devices and connected platform ecosystems Familiarity with human factors and usability engineering processes in compliance with regulated product development standards Proven ability to effectively collaborate with and influence internal and external stakeholders across various functional areas Experience supporting regulatory interactions with organizations such as the U.S. Food and Drug Administration (FDA), British Standards Institution (BSI), and TV