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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 & Verification (V&V): Executing rigorous testing to meet ISO 11607 standards, including Seal Integrity Testing: Bubble emission, dye penetration, or burst testing

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