R&D Sustaining Engineer I

Boston Scientific; Penang; On-site; MYR 170,000 - 227,000; Full time

Job summary

Boston Scientific in Galway is seeking an experienced R&D Engineer I to join the Interventional Cardiology and Vascular Therapies Sustaining R&D team. You will contribute to sustaining engineering, design changes and lifecycle support for a portfolio of coronary and vascular devices.

Working with senior engineers and cross-functional teams, you will analyse data, implement design improvements, manage risks, and ensure regulatory compliance across legacy and next‑generation products

Qualifications

• HETAC Level 8 Degree (or higher) in Mechanical, Biomedical, Polymer, Materials or a related Engineering discipline.
• 0 - 2 years relevant R&D engineering experience within the medical device industry or another highly regulated environment.
• Exposure in product development (NPD) and/or process development, with the ability to apply this knowledge to sustaining engineering and lifecycle management activities.
• Working knowledge of design controls, risk management, verification and validation, and change management within a regulated environment.
• Excellent analytical, problem-solving, communication and stakeholder management skills.

Responsibilities

• Support 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.
• Execute engineering tasks including testing, data analysis, documentation and verification activities.
• Collaborate with cross-functional teams including Manufacturing, Quality, Regulatory, Clinical, Marketing and Project Management to ensure successful project execution and product readiness.
• Support 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.
• Support continuous improvement by identifying and leading initiatives that enhance engineering processes, project execution and organisational effectiveness beyond individual projects.
• Continuously develop technical knowledge while contributing to team objectives.

Skills

Analytical skills

Problem solving

Communication

Stakeholder management

Education

HETAC Level 8 Degree in Mechanical/ Biomedical/ Polymer/ Materials

Job description

• Boston Scientific is seeking an experienced R&D Engineer I 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 and vascular intervention products, ensuring safety, regulatory compliance, manufacturing continuity and continuous product improvement throughout the product lifecycle.
• The successful candidate will contribute to sustaining engineering projects while developing technical expertise through collaboration with experienced engineers and cross-functional teams to identify and implement design improvements while supporting both legacy and next-generation technologies.
• Responsible for supporting the commercialization and lifecycle management of minimally invasive medical devices for the treatment of IC and VT disease.
• Working under guidance from senior engineers, the successful candidate will execute sustaining engineering and design change activities while developing technical knowledge of product design, manufacturing processes and regulatory requirements.
• 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.
• Identifies technical risks and opportunities early, proactively developing mitigation strategies that support project objectives, timelines and business priorities.

Purpose Statement

• Boston Scientific is seeking an experienced R&D Engineer I 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 and vascular intervention products, ensuring safety, regulatory compliance, manufacturing continuity and continuous product improvement throughout the product lifecycle.
• The successful candidate will contribute to sustaining engineering projects while developing technical expertise through collaboration with experienced engineers and cross-functional teams to identify and implement design improvements while supporting both legacy and next-generation technologies.
• Responsible for supporting the commercialization and lifecycle management of minimally invasive medical devices for the treatment of IC and VT disease.
• Working under guidance from senior engineers, the successful candidate will execute sustaining engineering and design change activities while developing technical knowledge of product design, manufacturing processes and regulatory requirements.
• 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.
• Identifies technical risks and opportunities early, proactively developing mitigation strategies that support project objectives, timelines and business priorities.

Job Responsibilities

• Support 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.
• Execute engineering tasks including testing, data analysis, documentation and verification activities.
• Collaborate with cross-functional teams including Manufacturing, Quality, Regulatory, Clinical, Marketing and Project Management to ensure successful project execution and product readiness.
• Support 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.
• Support continuous improvement by identifying and leading initiatives that enhance engineering processes, project execution and organisational effectiveness beyond individual projects.
• Continuously develop technical knowledge while contributing to team objectives.

Job Qualifications

• HETAC Level 8 Degree (or higher) in Mechanical, Biomedical, Polymer, Materials or a related Engineering discipline.
• 0 - 2 years relevant R&D engineering experience within the medical device industry or another highly regulated environment.
• Exposure in product development (NPD) and/or process development, with the ability to apply this knowledge to sustaining engineering and lifecycle management activities.
• Working knowledge of design controls, risk management, verification and validation, and change management within a regulated environment.
• Excellent analytical, problem-solving, communication and stakeholder management skills.

About Us

As a global medical technology leader for more than 40 years, our mission at Boston Scientific (NYSE: BSX) is to transform lives through innovative medical solutions that improve the health of patients. If you’re looking to truly make a difference to people both around the world and around the corner, there’s no better place to make it happen.