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Boston Scientific is seeking an experienced Senior Systems Engineer to join their Urology team in Clonmel, Ireland. This permanent role focuses on developing complex medical device product systems—including capital equipment, active implantable devices, and software-only products—from concept through market launch.
You will lead technical development efforts and collaborate with cross-functional teams to balance user needs, market opportunities, and business objectives. Key responsibilities include:
• Support acquisition and integration of complex capital equipment and active implantable systems, including due diligence, technology evaluation, gap assessment, and remediation planning
• Translate user needs into comprehensive design requirements (hardware, software, mechanical, electrical, cloud interfaces) at system and sub-system levels
• Define system architecture and design for new or next-generation implantable and capital platform ecosystems under Boston Scientific's quality system
• Identify technical risks, develop risk mitigation plans, and implement phased integration approaches and characterization studies
• Conduct systems requirements analysis to ensure testability and completeness; support test development and traceability
• Lead risk assessment activities, including Use/Design FMEA processes
• Support concept generation, functional prototyping, and design trade-off analysis
• Create and maintain documentation per Product Development Process and Quality Management System requirements
• Mentor junior engineers in systems engineering methodologies and domain knowledge
• Communicate findings and recommendations to senior leadership and stakeholders
Required qualifications: Bachelor's degree (Hons) or MSc in electrical, mechanical, biomedical engineering, or related field; 5+ years in product development (preferably 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; knowledge of system architectures and design principles; experience with configuration management, test management, requirements management, and issue tracking systems; ability to lead teams through structured problem-solving; strong design control and risk management knowledge; excellent communication and cross-functional collaboration skills.
Preferred: experience leading product development teams in regulated medical environments; building/modifying system architectures for implantable devices and connected platforms; human factors and usability engineering expertise; ability to interact with and influence internal/external stakeholders; experience with FDA, BSI, and TUV regulatory interactions.
