Systems Eng - P5

Additional Locations:  N/A

Principal Systems Engineer

About the role:

We are looking for an experienced Principal Systems Engineer to join the Boston Scientific Urology team. In this role, you will contribute technically and provide leadership in developing medical device product systems, including both capital equipment and active implantable, from initial concept through to product launch. Responsibilities also include supporting acquisition and integration of active implantable product systems, providing technical and engineering expertise.

The Systems Engineer considers both business and technical requirements to deliver a quality product that meets user needs. You will collaborate with cross-functional teams to balance user expectations, market opportunities, and business objectives.

In this role, you will lead engineering efforts to develop high quality, complex medical device systems including active implantable products, capital systems, combination medical devices, and software-only products—for market differentiation and growth within Urology franchises.

Your responsibilities will include:

• Support acquisition and integration activities for complex active implantable product systems. Provide due diligence support through technology evaluations, gap assessments and remediation planning including partnership with cross-functional teams. Support systems requirements and design modifications needed for seamless integration of product systems.

• For new product development, work with all stakeholders to translate user needs into design requirements (e.g. hardware, software, mechanical, electrical, cloud interface, etc.) consisting of system requirements, sub-system requirements, product/system security requirements, and system interface requirements to define the system as a whole and all associated sub-systems.
• Support system architecture, design and integration of new or next generation technologies/products (implantable & capital platform eco-systems) under BSC quality system in collaboration with technical/cross-functional stakeholders.
• Provide systems thinking perspective for system/sub-system definition and understand how product changes affect the larger system
• Identify technical risks, develop risk burndown plans, and implement phased system integration approaches, characterization studies to mitigate risk.
• Support special studies on subjects such as improving system quality, usability, system partitioning, trade off assessments etc. by researching and analyzing options for implementation.
• Analyzes system requirements to determine testability, completeness and support system test development, systems characterization, test method development and build traceability.
• Contribute to system risk assessment activities, Use/Design FMEA’s activities.
• Support product/feature design, concept generation and functional prototyping for systems and associated interfaces.

• Act as an R&D representative on cross-functional deliverables.

• Create and support documentation as part of the Product Development Process (PDP) and Quality Management System.
• Drive mechanisms for detailed project planning, tracking, and issue identification.
• Collaborate with R&D, regulatory, quality, project management teams for integration activities and communicate findings/recommendations to senior leadership and key stakeholders
• Provides leadership role on championing functional best practices and problem solving across functions/divisions and disciplines via internal/external experts to resolve difficult challenges.
• Builds Systems Engineering capability by mentoring engineers in engineering activities/methodologies and domain knowledge.
• Continuously improve processes and work methodologies (using agile/lean principles to eliminate waste) to help solve complex, interdisciplinary problems by interfacing with peers/cross-functional groups.

 Required qualifications:

• BS or MS in electrical engineering, computer science, biomedical engineering or related field
• 8+ years of experience with product development activities, preferred in a regulated environment. 
• Experience with requirements authoring design, trade-off analysis, systems integration, risk management and V&V processes.
• Proficiency in technical documentation, risk assessment and design control processes.
• Knowledge of Software and System Architectures and design principles.
• Experience using configuration management, test management, requirements management, and issue tracking systems.
• Ability to lead teams through a structured approach to solving complex technical problems.
• Strong knowledge of Design Controls & Risk Management practices
• Strong personal credibility & excellent communication skills
• Ability to work cross-functionally and communicate technical insights effectively

Preferred Qualifications & Experience 

• Experience leading product development teams in a Medical Regulated Environment.
• Experience in building and modifying System Architectures, Systems Requirements, Systems Design for implantable medical devices and connected platform eco-systems.
• Knowledgeable in Human Factors and Usability Engineering processes as part of regulated product development.
• Demonstrated ability to interact with and influence key stakeholders both internal and external to the organization.
• Experience dealing with regulatory questions from FDA, BSI, TUV

*Closing date 3rd October 2025*

Requisition ID: 614075