Senior Packaging Engineer
Senior Packaging Engineer
You will lead sterile medical device packaging activities for the Continence Care business unit and associated manufacturing sites. You will serve as a subject matter expert for new product development and commercialization, and changes to existing products. This includes packaging and labeling system development, manufacturing, and performance to the point of end use. You will also support business unit and departmental continuous improvement objectives.
This position is located in Ballina, Ireland and reporting into Global Packaging at corporate headquarters in Libertyville, IL.
- Apply advanced knowledge, under general guidance, on concepts, principles, and technical capabilities for projects of increased scope and complexity.
- Lead and support cross-functional projects for new product development and commercialization, and changes to existing products.
- Establish and manage packaging project schedules.
- Recommend and qualify new packaging materials, equipment, and suppliers.
- Develop and validate sterile packaging and labeling systems and equipment.
- Ensure compliance with and monitor changes to packaging regulations.
- Write and coordinate technical documentation, including design assurance documents, protocols, reports, procedures, specifications, work instructions, and original data.
- Develop and validate test methods.
- Source and validate packaging test equipment.
- Identify, lead, and support cost savings opportunities.
- Represent Hollister at industry events (conferences, seminars, etc.)
- Mentor peers within department
- Educate the organization on packaging best practices.
Work Experience Requirements
- Number of Overall Years Necessary: 5-8
- Sterile medical device packaging system development and validation
- Automated and manual packaging forming, loading, sealing, closing, and labeling equipment selection, development, and validation
- Form-fill-seal and heat seal equipment
- Sterile barrier seal tooling development
- Flexible barrier material performance and selection
- Porous and non-porous material performance and selection
- Design of experiment and process validation
- Statistical analysis
- Test methods for materials, integrity, physical properties, distribution simulation, and aging
- Fiber-based materials, including paperboard and corrugate
- Sterilization processes
- Labeling printers, application equipment, and vision systems
- Color specification
- Human factors and usability engineering
- Technical writing
- Optimization and cost savings
- Bachelor of Science in Packaging. Advanced degree desirable.
Specialized Skills/Technical Knowledge:
- Advanced knowledge of ISO 11607, EU MDR, UDI, ASTM D10 and F02, IEC 62366, and FDA Guidance on Applying Human Factors and Usability Engineering to Medical Devices
- Experience with Qumas, SAP, CAPE, TOPS, JMP, Minitab, Microscan
Local Specifications (English and Local Language):
- Fluent in English
For further information on this Senior Packaging Engineer role in Mayo please contact Amanda Reynolds on 0860468858/ firstname.lastname@example.org
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