Senior Packaging Engineer
CPL
MAYO
The Sr. Packaging Engineer will contribute to clients growth, profitability, and continuity by leading sterile medical device packaging activities for the business unit 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. Responsibilities. 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. 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. Develop and validate test methods. Source and validate packaging test equipment. Mentor peers within department. Work Experience Requirements. 5-8 Years experience. 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. Sterilization processes. Labeling printers, application equipment, and vision systems. Color specification. Human factors and usability engineering. Technical writing. Education. 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. Travel : 20% Stamp 4 Visa required for this role. Contact Brenda on 0858723761, brenda.flannery@cpl.ie.
1353 days ago