R&D Eng - P4

Job Purpose:

Boston Scientific is seeking a highly motivated Senior R&D Engineer to join the Galway Interventional Cardiology and Vascular Therapies (ICVT) Sustaining R&D team.

The ICVT Sustaining R&D group provides design leadership and technical support for a broad portfolio of commercial coronary intervention products, ensuring safety, regulatory compliance, manufacturing continuity and continuous product improvement throughout the product lifecycle.

The successful candidate will provide technical leadership across sustaining and strategic product initiatives, partnering with cross-functional teams to identify, evaluate and implement design improvements while supporting both legacy and next-generation technologies.

Key Responsibilities:

• Responsible for supporting the commercialization and lifecycle management of minimally invasive medical devices for the treatment of IC and VT disease.
• Working with a high degree of independence, the successful candidate will lead complex sustaining and design change activities, applying advanced engineering judgement to solve multifaceted technical challenges while balancing product performance, regulatory compliance, manufacturing capability and business needs.
• The role requires compiling, analysing and interpreting technical, operational and research data to make sound engineering recommendations and ensure product design intent is maintained throughout the product lifecycle.
• Acts as a technical expert within project teams, providing product and clinical expertise while influencing technical decisions across cross-functional stakeholders.
• Identifies technical risks and opportunities early, proactively developing mitigation strategies that support project objectives, timelines and business priorities. 
• Lead and execute sustaining engineering and design change activities, ensuring proposed product changes are supported by robust technical justification, risk assessment, verification and validation, and that design intent is maintained throughout the product lifecycle.
• Independently plan, prioritize and deliver technical workstreams, applying advanced engineering judgement to solve complex, multifaceted design, material and process challenges while meeting project timelines.
• Provide technical leadership across cross-functional teams including Manufacturing, Quality, Regulatory, Clinical, Marketing and Project Management to ensure successful project execution and product readiness.
• Lead structured problem-solving activities and quality investigations, identifying root causes and implementing effective corrective actions to maintain product safety, quality and performance.
• Identify technical risks and opportunities early, proactively developing mitigation strategies and driving decisions that positively impact product performance, cost, schedule and manufacturing continuity.
• Partner with Manufacturing and supplier teams to apply process development knowledge in implementing design improvements, supporting process optimisation and validation, and delivering continuous product, manufacturing and cost improvements across legacy and next-generation product portfolios.
• Analyse, interpret and communicate technical, operational and research data, preparing clear engineering documentation and recommendations to support technical and business decisions.
• Act as a technical expert for commercial products, applying product, clinical and anatomical knowledge to evaluate field feedback, support physicians where appropriate, and identify opportunities for product enhancement.
• Drive continuous improvement by identifying and leading initiatives that enhance engineering processes, project execution and organisational effectiveness beyond individual projects.
• Provide technical guidance and mentoring to other engineers, influencing technical decisions and promoting best engineering practices within multidisciplinary and global project teams.

Education & Experience:

• Honours bachelors degree Level 8 (or higher) in Mechanical, Biomedical, Polymer, Materials or a related Engineering discipline.
• 8 years' + relevant R&D engineering experience within the medical device industry or another highly regulated environment.
• Demonstrated experience in product development (NPD) and/or process development, with the ability to apply this knowledge to sustaining engineering and lifecycle management activities.
• Proven experience leading technical workstreams, design changes or complex engineering projects in a cross-functional environment.
• Strong understanding of design controls, risk management, verification and validation, and change management within a regulated environment.
• Excellent analytical, problem-solving, communication and stakeholder management skills, with the ability to influence technical decisions and mentor less experienced engineers.

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