Medical Device R&D Engineer – Penang

Ambu A/S; George Town; On-site; MYR 60,000 - 90,000; Full time

Job summary

Ambu A/S in Penang, Malaysia, is seeking an R&D Product Engineer to join the Lifecycle Engineering team. You will lead product design and life cycle management projects, and provide hands-on technical expertise across cross-functional teams.

The role emphasizes design control, verification activities, and documentation updates to ensure regulatory compliance. Strong English communication and independent, structured work style are essential for success in our international environment.

Qualifications

• 2–3 years' experience leading projects with measurable results.
• Experience in Medical Device industry including Design Control is a plus.
• Able to understand technical details of product/process applications.
• Strong interpersonal, organizational, and cross-functional coordination skills.
• Proficient in written and spoken English at negotiating level.

Responsibilities

• Lead in product design and development of product specifications, technical sourcing of materials and documents implementation of Life Cycle Management projects.
• Lead, participate, investigate, develop, and provide technical expertise input / hands-on to Life Cycle Management verification activities.
• Initiate or support design changes in Ambu system according to procedures and are reviewed and approved according to regulatory and Ambu requirements.
• Lead the review and update of relevant QHBs and R&D documentation to ensure alignment and compliance with regulatory and Ambu requirements.
• Lead in product test method validation in Life Cycle Management activities.
• Support product shelf-life verification and extension.

Skills

Project leadership

Cross-functional teamwork

English communication

Independent work

Structured & systematic

Job description

Ambu A/S in Penang, Malaysia, is seeking an R&D Product Engineer to join the Lifecycle Engineering team. You will lead product design and life cycle management projects, and provide hands-on technical expertise across cross-functional teams.

The role emphasizes design control, verification activities, and documentation updates to ensure regulatory compliance. Strong English communication and independent, structured work style are essential for success in our international environment.