R&D Sustaining Engineer I

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

Job summary

Boston Scientific seeks an experienced R&D Engineer I in Malaysia to join the Sustaining R&D team. You will contribute to sustaining projects for interventional cardiology and vascular therapies, supporting legacy and next-generation devices, while ensuring design intent and regulatory compliance throughout the lifecycle.

You will work under guidance to perform testing, data analysis, and design change activities, collaborating with Manufacturing, Quality, Regulatory, Clinical, Marketing and

Qualifications

• Proven ability to analyze data and draw engineering conclusions.
• Strong problem-solving and communication skills across teams.
• Experience collaborating with cross-functional groups (Manufacturing, Quality, Regulatory, Clinical).

Responsibilities

• Support sustaining engineering and design change activities with robust justification and risk assessment.
• Perform testing, data analysis, documentation and verification activities.
• Collaborate with Manufacturing, Quality, Regulatory, Clinical, Marketing and Project Management for project readiness.
• Assist in root-cause investigations and implement corrective actions to maintain product safety and performance.
• Identify risks and opportunities early and develop mitigation strategies to meet timelines and costs.
• Work with suppliers to apply process development knowledge and deliver product and cost improvements across portfolios.
• Prepare clear engineering documentation to support technical and business decisions.
• Contribute to continuous improvement of engineering processes and team effectiveness.

Skills

Analytical thinking

Problem solving

Communication

Stakeholder management

Education

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

Job description

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• 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.

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