R&D Product Engineer: Medical Device Lifecycle Lead

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 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.