Senior R&D Engineer

Position Summary

The incumbent is responsible for developing and implementing new medical device products and new technologies through adherence to established strict quality management system processes and practices.

Responsibilities

• To lead or support the full new medical device product development project lifecycles from concept stage to verification and validation and to manufacturing transfer and product launch.
• To lead or actively participate in new product introduction and / or transfer projects, continuous improvements projects, and sustaining activities.
• To actively participate in all projects and act as the technical lead for cross-functional teams as needed
• To provide guidance to junior engineers and technicians, and assist in lab management
• To lead for manufacturing line set up, installation and qualification of equipment
• To support production manufacturing, inspection process, and sustenance of the line
• To continuously support for equipment and facility related maintenance, monitoring and calibration
• Others like sourcing for external R&D materials for testing

Requirements

• Minimum Degree in Material/Chemical or relevant.
• 5-8 years relevant working experience in a regulated industry preferred.
• Good product design and process development knowledge and experience with strong analytical skills.
• Experience with medical device, especially device-drug combination product design, manufacturing or regulatory affairs in a medical device area will be beneficial.
• Strong verbal and written communication skills to cooperate with Asia and Global teams
• Proven strong team player with good interpersonal and communication skills.
• Good technical documentation skills relevant to professional reports