Packaging Engineer

Packaging Engineer

Cincinnati, OH

Skills : Material and packaging test methods, ISO11607-1/-2 and ISO13485, Artios CAD, CAPE Pack, TOPS

• Familiarity with Good Manufacturing Practices (GMPs)
• ISO regulations (ISO11607-1/-2 and ISO13485)
• Proficiency in material and packaging test methods (ASTM and ISTA) and sterilization processes
• sterile medical device experience
• Familiarity with packaging-related design software (Artios CAD, CAPE Pack, TOPS, etc.)
• Packaging Project Support: Participate in packaging related projects by developing requirements, planning, designing, sourcing, and implementing packaging systems for sterile and non-sterile medical device products.
• Cross-Functional Collaboration: Work collaboratively with cross-functional teams on New Product Development and commercial change projects, contributing to packaging system development.
• Process Development: Contribute to the selection of manufacturing equipment and assist in process development, including IQ, OQ, PQ activities.
• Material and Technology Evaluation: Evaluate new packaging and labeling technologies and support line trials and packaging validation activities prior to the introduction of any new components/processes.
• Risk Management: Perform risk management activities within the quality management system by utilizing appropriate design controls.
• Verification and Validation Support: Support Verification and Validation (V&V) activities by working closely with the V&V team and external testing facilities.
• Technical Evaluations: Conduct engineering studies to perform technical evaluations and testing to support reports justifying the use of selected materials and packaging components.
• Capability to work independently with minimal supervision and collaborate effectively with cross-functional teams
• Experience in project management or project planning, the ability to handle multiple projects simultaneously