R&D Sustaining Engineer I — Medical Devices

Boston Scientific Gruppe; Malaysia; On-site; MYR 60,000 - 90,000; Full time

Job summary

Boston Scientific is seeking an experienced R&D Engineer I to join the Galway Interventional Cardiology and Vascular Therapies Sustaining R&D team. You will contribute to sustaining engineering projects and support design changes across legacy and next-generation products.

Under guidance from senior engineers, you will analyze data, verify changes, and collaborate with Manufacturing, Quality, Regulatory and Marketing to ensure product safety, quality and lifecycle management.

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 thinking

Problem solving

Communication

Stakeholder management

Education

HETAC Level 8 Degree in Mechanical, Biomedical, Polymer, Materials or related Engineering

Tools

Design controls

Risk management

Verification & Validation

Change management

Job description

Boston Scientific is seeking an experienced R&D Engineer I to join the Galway Interventional Cardiology and Vascular Therapies Sustaining R&D team. You will contribute to sustaining engineering projects and support design changes across legacy and next-generation products.

Under guidance from senior engineers, you will analyze data, verify changes, and collaborate with Manufacturing, Quality, Regulatory and Marketing to ensure product safety, quality and lifecycle management.