Packaging Engineer - Mirox Project
On-siteMelbourne, Victoria, Australia
Job Summary
Execute packaging validation activities, including planning, execution, and documentation of tests for equipment, sealing processes, and transportation stability. Develop protocols, test plans, and define test cases aligned with ISO 11607-1 and ISO 11607-2 requirements. Collect, analyze, and interpret validation data using statistical methods and Minitab to support regulatory review and audits. Design and improve manufacturing and testing tools to enhance efficiency and repeatability while maintaining compliance with GMP, QMS, and Australian Medical Device Regulations. Collaborate cross-functionally with engineering, quality, and project teams to ensure timely delivery of the Mirox packaging project.
Required Qualifications
- Strong foundational knowledge of mechanical engineering principles applied to medical device packaging systems
- Demonstrated understanding of ISO 13485 and GMP principles, including documentation control, validation lifecycle, risk management, and data integrity
- Working knowledge of ISO 11607 (Parts 1 and 2) and relevant ASTM packaging standards (e.g. ASTM F88/F88M, F1140/F1140M, F1929, F2052, F1980)
- Ability to read, interpret, and apply regulatory standards, technical specifications, and internal procedures
- Statistical analysis capability, including use of Minitab software for data analysis, capability studies, trend analysis, and report generation
- Ability to analyze and present technical data in formats suitable for validation reports, regulatory review, and audits
- Strong communication and collaboration skills, with the ability to manage multiple tasks in a multidisciplinary, regulated manufacturing environment
- Hands-on experience or aptitude in using packaging testing equipment and production tools
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