Sr. Engineer Packaging
2000 Hollister Drive Libertyville, IL 60048 US
Summary Global Packaging serves its product end users by providing packaging engineering expertise to develop optimized and compliant packaging systems. We help our organization drive cost competitiveness, improve operating efficiencies and effectiveness, and sustain performance in quality, service, and product commercialization.
The Packaging Engineer will contribute to growth, profitability, and continuity by leading medical device packaging activities for the Ostomy and Continence Care business units and associated manufacturing sites. They 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. They will also support business unit and departmental continuous improvement objectives. This position reports into Global Packaging at corporate headquarters in Libertyville, IL. Operating in a hybrid working environment.
- Apply advanced knowledge, under general guidance, on concepts, principles, and technical capabilities for projects of increased scope and complexity.
- Support cross-functional projects for new product 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 and non-sterile packaging and labeling systems and equipment.
- Ensure compliance with and monitor changes to packaging regulations and standards.
- 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 and support cost savings opportunities.
- Represent client at industry events (conferences, seminars, etc.)
- Educate the organization on packaging best practices.
- Mentor peers within the department.
Essential Functions of the Role
- Periodic laboratory testing and travel to plants to conduct packaging validations on the manufacturing floor.
Work Experience Requirements
- Number of Overall Years Necessary: 7-11 Sterile medical device packaging system development and validation
- Advanced knowledge of sterile barrier system development, validation, equipment, and associated sterilization processes
- Automated and manual packaging forming, loading, sealing, closing, and labeling equipment selection, development, and validation
- Form-fill-seal, heat seal, and closure equipment/tooling
- Flexible (porous and non-porous) and rigid sterile barrier material performance and selection
- Fiber-based materials, including paperboard and corrugate
- Design of experiment and packaging process validation
- Advanced statistical analysis
- Test methods for materials, integrity, physical properties, distribution simulation, and aging
- Sterilization processes
- Labeling printers, application equipment, and vision systems
- Printed color specification
- Technical writing
- Optimization and cost savings
- Bachelor of Science in Packaging. Advanced degree desirable.
Specialized Skills/Technical Knowledge
- Advanced knowledge of ASTM D10 and F02 and ISO 11607
- Moderate knowledge of EU MDR, UDI, IEC 62366, and FDA Guidance on Applying Human Factors and Usability Engineering to Medical Devices
- Advanced experience with Qumas, SAP, CAPE, TOPS, JMP, Minitab, Microscan or similar
- Local Specifications (English and Local Language) Fluent in English