Global Medical Device Project Manager - NPD & Manufacturing

Ambu; Penang; On-site; MYR 180,000 - 250,000; Full time

Job summary

Ambu is seeking an experienced Project Manager to join the Respiratory & ENT Solutions team within Global R&D at our innovation site in Penang, Malaysia. You will drive complex product development projects from idea to implementation, coordinating across functions and external partners while ensuring regulatory and quality standards.

The role requires strong leadership, technical and business understanding, and the ability to manage timelines, budgets and risks.

Qualifications

• Degree in engineering or relevant technical discipline; ability to support decision-making and challenge technical solutions when needed.
• Solid project management experience within the medical device industry, preferably involving New Product Development, industrialization or manufacturing.
• Broad project management toolbox; capable of managing scope, timelines, resources, risks and budgets.
• Experience working with global project teams and international suppliers.
• Curious, open-minded and able to build strong relationships across functions and cultures.
• Structured, committed and ownership mindset for both projects and team.
• Demonstrate strong leadership and stakeholder-management skills.
• Preferably hold a recognized Project Management certification.
• Experience with development of Class II medical devices is an advantage.

Responsibilities

• Develop, coordinate and execute project plans for new product and product line development in accordance with New Product Development projects.
• Define project scope, objectives, deliverables and success criteria in collaboration with project management, sponsors and key stakeholders.
• Plan and manage project timelines, milestones, resources, risks and dependencies using appropriate project management tools.
• Ensure the right competencies and resources are available throughout the different phases of the project.
• Prepare investment applications and ensure projects are managed within the approved budget.
• Monitor project progress and proactively address issues, risks and changes.
• Lead and coordinate project meetings and ensure effective collaboration across global project teams and third-party suppliers.
• Ensure project status, risks and issues are clearly communicated and escalated when needed.
• Apply project management best practices and continuously improve ways of working based on learnings from projects.
• Ensure project activities and documentation comply with Ambu’s Quality Management System and applicable regulatory requirements.

Skills

Project management

Medical device industry experience

Leadership

Stakeholder management

Cross-functional collaboration

Risk management

Budget management

Technical background

Education

Engineering degree or relevant technical discipline

Job description

Ambu is seeking an experienced Project Manager to join the Respiratory & ENT Solutions team within Global R&D at our innovation site in Penang, Malaysia. You will drive complex product development projects from idea to implementation, coordinating across functions and external partners while ensuring regulatory and quality standards.

The role requires strong leadership, technical and business understanding, and the ability to manage timelines, budgets and risks.