Job Details A Packaging Engineer is responsible for the design, development, and testing of packaging systems to protect products, minimize costs, and ensure sustainability. They bridge the gap between R&D and technical engineering to ensure a product moves safely and efficiently from the manufacturer to the final consumer. The role for a Packaging Engineer shift from general logistics to a critical function of patient safety and regulatory compliance. Their primary objective is to develop packaging that maintains a sterile barrier and ensures a device remains functional until the moment of use. Core Responsibilities Design & Prototyping: Creating structural packaging designs using CAD software (e.g., SolidWorks, AutoCAD) for primary, secondary, and tertiary layers. TOPS software is desired. Sterile Barrier System (SBS) Design: Designing primary packaging (e.g., pouches, trays) that allows for terminal sterilization (Ethylene Oxide, Gamma, E‑Beam, etc.) while preventing microbial ingress. Material Selection: Evaluating and selecting materials—such as plastics, paperboard, glass, or metals—based on product requirements, cost, and environmental impact. Performance Testing: Developing and executing test protocols (e.g., ISTA, ASTM) to validate packaging durability against hazards like vibration, shock, moisture, and temperature fluctuations. Regulatory Documentation: Authoring highly technical protocols and reports for FDA or EU MDR submissions, including Design History Files (DHF) and Technical Files. Validation and Verification (V&V): Executing rigorous testing to meet ISO 11607 standards, including Seal Integrity Testing: Bubble emission, dye penetration, or burst testing EEO Policy Statement #J-18808-Ljbffr