R&D Sustaining Engineer I - Medical Devices

Boston Scientific Medical Device (Malaysia) Sdn. Bhd.; Penang; On-site; MYR 45,000 - 70,000; Full time

Job summary

Boston Scientific Medical Device (Malaysia) Sdn. Bhd.

in Penang is seeking an experienced R&D Engineer I to join the Interventional Cardiology and Vascular Therapies Sustaining R&D team, contributing to sustaining engineering and design improvements across legacy and next-generation products. Under guidance from senior engineers, you will perform testing, data analysis, documentation, and risk assessment, and collaborate with cross-functional teams to ensure product safety, quality and

Qualifications

• 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 sustaining engineering and lifecycle management.
• 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 with robust justification, risk assessment, verification and validation.
• Execute engineering tasks including testing, data analysis, documentation and verification activities.
• Collaborate with Manufacturing, Quality, Regulatory, Clinical, Marketing and Project Management to ensure project execution and product readiness.
• Support structured problem-solving activities and quality investigations to maintain safety, quality and performance.
• Identify risks and opportunities early and develop mitigation strategies impacting performance, cost and schedule.
• Partner with Manufacturing and supplier teams to implement design improvements and process validation across legacy and next-generation products.
• Analyze and communicate technical data to support technical and business decisions.
• Lead continuous improvement initiatives in engineering processes and project execution.

Skills

Analytical thinking

Problem-solving

Communication

Stakeholder management

Education

HETAC Level 8 Degree or higher in Mechanical Engineering

Job description

Boston Scientific Medical Device (Malaysia) Sdn. Bhd.

in Penang is seeking an experienced R&D Engineer I to join the Interventional Cardiology and Vascular Therapies Sustaining R&D team, contributing to sustaining engineering and design improvements across legacy and next-generation products. Under guidance from senior engineers, you will perform testing, data analysis, documentation, and risk assessment, and collaborate with cross-functional teams to ensure product safety, quality and