R&D Product Engineer

Ambu A/S; Malaysia; On-site; MYR 60,000 - 85,000; Full time

Job summary

Ambu A/S in Penang, Malaysia, seeks an R&D Product Engineer to drive design and development of medical devices and lifecycle management. The role reports to the Section Manager, R&D Lifecycle Engineering, and suits someone passionate about medical device design and development.

Key responsibilities include leading product design, lifecycle verification activities, and documentation updates to ensure regulatory compliance.

Qualifications

• Minimum 2-3 years' experience leading projects with documented results.
• Experience from Medical Device industry including Design Control is a plus.
• Ability to understand technical details of product/process applications.
• Excellent interpersonal, organizational, coordination, and problem-solving skills.
• English written and spoken at negotiation level.
• Able to work independently in a cross-cultural team.

Responsibilities

• Lead in product design and development of specifications, sourcing of materials, and Life Cycle Management documentation.
• Lead and support Life Cycle Management verification activities.
• Initiate or support design changes according to procedures and regulatory requirements.
• Lead the review and update of QHBs and R&D documents for compliance.
• Lead product test method validation in Life Cycle Management.
• Support product shelf-life verification and extension.

Skills

Project leadership

Cross-functional teams

Interpersonal skills

English proficiency

Independent work

Technical understanding

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 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.

About Ambu

Ambu has been bringing the solutions of the future to life since 1937. Today, millions of patients and healthcare professionals worldwide depend on the efficiency, safety and performance of our single-use endoscopy, anaesthesia, and patient monitoring solutions. We continuously look to the future with a commitment to deliver innovative quality products that have a positive impact on patient care and the work of healthcare professionals. Headquartered near Copenhagen in Denmark, Ambu employs approximately 4,500 people in Europe, North America and the Asia Pacific.