Job Description

Ambu A/S is currently looking for a Senior Engineer, Project Management to be based in Penang, Malaysia.

This position is reporting to Section Manager of Project Management.

Key responsibilities

Your main responsibilities will include:

• Develop and manage project with clear scope, goals, and deliverables alignment with business objectives and comply with applicable medial device regulations and standards.
• Allocate, manage and track project timelines, resources, risks and budgets including periodic project overview meeting with the team, vendor alignment, and project docuemntation.
• Provide support throughout the project lifecycle, whether through support or direct involvement in technical issues, documentation management or validation activities to ensure successful, on-time project delivery.

• Support and involve in process improvement or quality issues related to existing validated processes, handle NCRs and CAPAs, and provide technical or validation support plus problem solving.

• Support audits activities such as IQA, ISO, FDA, etc.

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 education of Bachelor’s Degree in Mechanical or other engineering disciplines or science disciplines.

• Minimum 3 years of working experience. Experience in medical device industry will be given priority.

• Proven technical and problem-solving skills to ensure optimal project execution and implementation.

• Knowledge in medical industry documentation will be an added advantage.

• Experience in FDA requirements, Design Control, Process Validation and ISO 13485 will be an added advantage.

• Good communication to manage different level of stakeholders. Proficient in English.

• Good time management skills.

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.