R&D Product Engineer

Ambu; Penang; On-site; MYR 67,000 - 100,000; Full time

Job summary

Ambu A/S is seeking an R&D Product Engineer to be based in Penang, Malaysia, reporting to the Section Manager, R&D Lifecycle Engineering. You will lead product design and development, drive Life Cycle Management projects, and support design changes per regulatory requirements.

The ideal candidate has 2–3 years of project leadership in medical devices and strong cross‑functional collaboration, with English proficiency.

Qualifications

• 2–3 years leading projects with documented results.
• Experience in Medical Device industry, including Design Control and mass production exposure.
• Ability to understand technical details of product/process applications.
• Strong interpersonal, organizational and problem‑solving skills in cross‑functional teams.
• Proficient written and spoken English.
• Work independently, in a structured and cross‑cultural environment.

Responsibilities

• Lead in product design and development of specifications and materials.
• Lead life cycle management verification activities and document implementation.
• Initiate or support design changes per regulatory and Ambu requirements.
• Lead review and update of QHBs and R&D documentation for compliance.
• Lead product test method validation in Life Cycle Management.
• Support product shelf-life verification and extension.

Skills

Project leadership

Design control

Cross-functional teamwork

English proficiency

Independent, structured work

Job description

Ambu A/S is currently looking for a R&D Product Engineer to be based in Penang, Malaysia.

This position reports to the Section Manager, R&D Lifecycle Engineering. This position is ideal for someone who is passionate in medical device design & development.

Key Responsibilities

Your main responsibilities will include

• 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.

Suggested candidate profile

Skills

Skills and experiences can be earned in many different ways, and we understand that the best fit for the role cannot be prescribed on paper. You are however likely to succeed in this position if you:

• Minimum 2 - 3 years' experience in leading projects and can document good results, including motivating and delegating to project team members.
• An added advantage if he / she have relevant experience from Medical Device industry, including Design Control and involved in mass production environment.
• Be capable of understanding technical details product/process applications, thereby ensuring the optimal implementation of design change.
• Demonstrates excellent interpersonal communication, organizational, coordination, and problem-solving skills, especially in cross-functional teams.
• Be proficient in written and spoken English at negotiation level. Good interpersonal skills.
• Work independently, structured and systematic. Able to work in a cross-cultural team.

Ambu – a visionary and international workplace where your efforts matter

Ambu is a company that expands rapidly and has ambitious growth targets. We meet these targets through interdisciplinary teamwork between motivated and highly skilled employees. Your contributions and efforts are crucial to our success and by joining us you will get the opportunity to work in an international head office with an informal working environment.

We offer great opportunities for personal development. Furthermore, we offer a wide range of professional, social and financial employee benefits in addition to exciting job challenges and continuous professional and personal development.