Job Description

Ambu is currently looking for a Staff R&D Packaging Engineer.

This position reports to the Senior Manager Lean, Continuous Improvement and Packaging. If you are from medical device industry with experience in any R&D function, this position would be suitable for you.

Key responsibilities

• Lead the development of packaging solutions for new platform products and lifecycle products that protect products during transportation, storage, and handling according to International Standard and Ambu Quality System.
• Design and develop product packaging by using inventor or equipvalent CAD software for the new platform and lifecycle products that meet technical specification, cost, time, reliability and quality requirements.
• Generate product packaging prototype, conduct detailed feasibility studies, material evaluations, and performance testing to optimize packaging design and functionality according yo medical packaging standard eg. ISO 11607 and ASTM D4167.
• Ensure packaging solution is optimize during sterilization by conduct palletization analysis with using simulation software, eg.Topspro.
• Create packaging technical artwork specifications/ documents according to Ambu Quality System.
• Develop and/or evaluate packaging process and equipment to ensure optimal performance and efficiency.
• Conduct feasibility studies and/or Process Capability studies for new packaging processes and equipment to ensure manufacturability.
• Subject matter expert responsible for technical assessments of supplier and/or internal changes, cost saving initiative, failures of investigation, and corrective actions related to packaging.
• Support on ad hoc task eg. marketing tender request but not limited to Internal & external audits related to the packaging design and process.
• Mentor junior packaging engineers in day-to-day activities related to product packaging, provide technical know-how and share expertise.

Suggested candidate profile

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

• Bachelor's degree in Mechanical, Material Science or Design Engineering or any equivalent engineering field.
• Minimum 5years of proven experience in product packaging design, development, and qualification of packaging systems for new and lifecycle products.
• Knowledge in medical device pacakging regulatory requirments such as FDA, EU MDR and testing standard according to ISO and ASTM standard.
• Good understanding of the materials, processes, and technologies involved in packaging production.
• Must be good in packaging design skills with 2D/3D CAD modeling. eg. Autodesk, Inventor.
• Good knowledge in technical critical thinking intepreting data results, demonstrating equipvalency and/or technical rationales for medical device packaging design.
• Some years of experience in medical device industry.
• Ability to work independently with minimum supervision, structured and systematic.
• Excellent written and oral communication skills, with ability to create and deliver presentations to both technical and non-technical audiences.