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Job description
About the Role and Company
LivaNova is a global medical technology company dedicated to transforming lives through innovative healthcare solutions. They are committed to excellence in patient outcomes and advancing medical device technology. This opportunity offers a chance to join a forward-thinking team focused on improving medical device packaging systems.
Job Overview
The Packaging Engineer provides key support to packaging projects by acquiring comprehensive knowledge in medical device packaging manufacturing and validation. The role ensures compliance with Good Manufacturing Practice (GMP), LivaNova policies, their Quality Management System (QMS), Australian Medical Device Regulations, ISO 13485/11607, ASTM packaging standards, and other relevant regulatory requirements.
Key Duties and Responsibilities
- Assist in planning, executing, and documenting medical device packaging testing adhering to ISO 11607 and ASTM standards.
- Help develop, carry out, and document packaging validation processes including packaging equipment validation, seal testing, and transport/stability simulations.
- Gather, evaluate, and interpret packaging validation and test results applying statistical analysis techniques.
- Contribute to the creation of validation protocols, test plans, and case definitions aligned with ISO 11607 parts 1 and 2.
- Support the design and enhancement of packaging manufacturing and testing tools to boost efficiency and repeatability.
- Identify and assist in implementing workflow, material, and integration improvements in packaging processes.
- Create, review, and maintain packaging validation documentation adhering to LivaNova’s QMS standards.
- Collaborate across functions with engineering, quality, manufacturing, external labs, and project teams to ensure on-time delivery of the Mirox packaging project.
Qualifications and Requirements
- Strong grounding in mechanical engineering principles relevant to medical device packaging systems.
- Understanding of ISO 13485 and GMP including document control, validation lifecycle management, risk assessment, and data integrity.
- Working knowledge of ISO 11607 (Parts 1 & 2) and ASTM packaging standards, including ASTM F88/F88M, F1140/F1140M, F1929, F2052, and F1980.
- Capability to interpret and apply regulatory standards, technical documents, and internal procedures.
- Competency in statistical data analysis using Minitab for capability studies, trend identification, and report writing.
- Ability to present technical data effectively for validation reports, regulatory submissions, and audits.
- Strong interpersonal and teamwork skills suitable for managing multiple tasks in a highly regulated manufacturing environment.
- Practical experience or strong interest in utilizing packaging testing machines and production tools.
Tools and Technology Utilized
- Desktop or laptop computers
- Microsoft Office Suite
- Minitab statistical software
- Siemens Solid Edge CAD hardware and software
- Photocopiers and printers
- EXACT ERP software
- Packaging and mechanical testing equipment such as seal strength testers, burst testers, dye penetration testers, vernier calipers, micrometers, and hardness testers
Additional Information
This role is based in Dandenong South, Victoria, Australia and requires onsite presence. Joining LivaNova means contributing to innovation that impacts patient lives worldwide.