Boston Scientific is hiring a Senior R&D Engineer on a permanent basis. In this role, you will contribute technically to the development of complex medical device product systems, including capital equipment and active implantables, from initial concept through to product launch. You will also support acquisition and integration activities, providing critical technical and engineering expertise.
What You'll Do
- Support acquisition and integration activities for complex capital equipment and active implantable product systems, providing due diligence support through technology evaluations, gap assessments, and remediation planning.
- Work with stakeholders to translate user needs into comprehensive design requirements, including system, sub-system, security, and interface requirements.
- Support system architecture, design, and integration of new or next-generation technologies and products under the BSC quality system.
- Apply a systems thinking perspective to understand how product changes affect the larger system and provide technical leadership.
- Identify technical risks, develop risk burndown plans, and implement phased integration approaches and characterization studies to mitigate risk.
- Support special studies on system quality, usability, partitioning, and trade-off assessments by researching and analyzing implementation options.
- Analyze system requirements to determine testability and completeness, supporting test development, characterization, and traceability.
- Contribute to system risk assessment activities, including Use and Design FMEAs.
- Support product/feature design, concept generation, and functional prototyping for systems and interfaces.
- Act as an R&D representative on cross-functional deliverables and collaborate with teams for integration activities.
- Create and support documentation as part of the Product Development Process (PDP) and Quality Management System.
- Communicate findings and recommendations to senior leadership and key stakeholders.
- Build Systems Engineering capability by mentoring engineers in methodologies and domain knowledge.
What We're Looking For
- Hons bachelor’s degree or MSc in electrical engineering, mechanical engineering, biomedical engineering, or a related field.
- 5+ 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 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 and excellent communication skills.
- Ability to work cross-functionally and communicate technical insights effectively.
Nice to Have
- Experience leading product development teams in a Medical Regulated Environment.
- Experience in building and modifying System Architectures, Systems Requirements, and 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.
Team & Environment
Join the Boston Scientific Urology team. Our culture is built on diversity, innovation, caring, global collaboration, a winning spirit, and high performance.
Boston Scientific is proud to be an equal opportunity and affirmative action employer. We stand for inclusion, equality, and opportunity for all.
