Sustaining R&D Engineer II - Medical Devices

Boston Scientific; Penang; On-site; MYR 307,000 - 425,000; Full time

Job summary

Boston Scientific is seeking an experienced R&D Engineer II to join the Galway ICVT Sustaining R&D team. You will independently execute sustaining engineering projects and collaborate with cross-functional teams to implement design improvements across legacy and next-generation technologies.

The role focuses on lifecycle management of minimally invasive devices for interventional cardiology and vascular therapies, balancing product performance, regulatory compliance and manufacturing

Qualifications

• Sustaining engineering experience in medical devices or regulated environments.
• Experience with design changes and lifecycle management.
• Knowledge of design controls, risk management, and validation processes.
• Strong analytical and stakeholder management skills.

Responsibilities

• Execute sustaining engineering and design change activities with robust justification and risk assessment.
• Plan, prioritize and deliver technical workstreams to meet project timelines.
• Collaborate with Manufacturing, Quality, Regulatory, Clinical, Marketing and PM teams.
• Lead problem-solving activities and implement corrective actions for safety and performance.
• Identify risks early and develop mitigation strategies affecting cost, schedule and manufacturing.
• Partner with Manufacturing and supplier teams to implement design improvements and validations.
• Analyze and communicate technical data to support technical and business decisions.
• Act as a technical expert for commercial products and assist physicians where appropriate.
• Drive continuous improvement in processes and project execution.

Skills

Sustaining engineering

Design changes

Cross-functional collaboration

Technical analysis

Regulatory compliance

Manufacturing support

Risk assessment

Education

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

Job description

Boston Scientific is seeking an experienced R&D Engineer II to join the Galway ICVT Sustaining R&D team. You will independently execute sustaining engineering projects and collaborate with cross-functional teams to implement design improvements across legacy and next-generation technologies.

The role focuses on lifecycle management of minimally invasive devices for interventional cardiology and vascular therapies, balancing product performance, regulatory compliance and manufacturing