- Location
- Australia_Chelsea Heights_1/63 Wells Road
- Type
- Full-time
- Department
- Engineering
- Source
- Workday
Description
As a global medtech company, we are driven by our Vision of changing the trajectory of lives for a new day and our Mission to create ingenious solutions that ignite patient turnarounds. Our relentless commitment to patients and strong legacy of innovation in healthcare are the foundation of our future. If you're looking for a new chance, a new beginning, a new trajectory, LivaNova is where your talent can truly thrive. Join our talented team members worldwide to become a pioneer of tomorrow—because at LivaNova, we don’t just treat conditions — we aspire to alter the course of lives.
Job Summary
Support the packaging projects by gaining in-depth knowledge of medical device packaging manufacturing and validation processes. The role ensures that the medical device packaging activities comply with GMP, LivaNova policies, the Quality Management System (QMS), Australian Medical Device Regulations, ISO 13485/11607, and applicable ASTM packaging standards, as well as other relevant statutory and regulatory requirements.
Duties and Responsibilities
- Assist in the planning, execution, and documentation of medical device packaging tests in accordance with ISO 11607 and applicable ASTM standards.
- Support the development, execution, and documentation of packaging validation activities, including packaging equipment, sealing processes, and transportation/stability simulation.
- Collect, analyze, and interpret packaging validation and test data using appropriate statistical methods.
- Assist in developing packaging validation protocols, test plans, and defining test cases aligned with ISO 11607-1 and ISO 11607-2 requirements.
- Support the design, development, and improvement of packaging-related manufacturing and testing tools to enhance efficiency, accuracy, and repeatability.
- Identify and assist in implementing improvements to packaging workflows, materials, and integration with manufacturing processes.
- Create, review, and maintain packaging validation documentation in compliance with LivaNova’s Quality Management System (QMS).
- Support cross-functional collaboration with packaging engineering, quality, manufacturing, external laboratory and project teams to ensure timely delivery of the Mirox packaging project.
Requirements for the Role
- 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.
Tools and Technologies Used in the Role
- Desktop and/or laptop computers
- Microsoft Office Suite
- Minitab statistical software
- Computer-Aided Design (CAD) hardware and software (Siemens Solid Edge)
- Photocopiers and printers
- EXACT ERP software
- Packaging and mechanical testing equipment (e.g. seal strength tester, burst tester, dye penetration tester, vernier calipers, micrometers, hardness testers)
