Job Description

• The Medical Device Packaging Engineer is responsible for the design, development, validation, and continued support of sterile and non-sterile packaging systems and associated manufacturing processes. This role ensures packaging and manufacturing solutions meet regulatory, quality, sterilization, and cost requirements, while supporting product development, sustaining engineering, and operational excellence.

• Design and develop primary, secondary, and tertiary packaging systems for medical devices.
• Select and qualify packaging materials (pouches, blisters, trays, cartons, labels).
• Support packaging line setup, equipment qualification, and process optimization.
• Develop and maintain manufacturing processes aligned with product and packaging requirements.
• Drive cost reduction and efficiency improvements without compromising quality or compliance.

• Lead and/or support packaging and manufacturing validations, including:
• IQ / OQ / PQ.
• Package integrity testing (seal strength, bubble leak, dye penetration).
• Distribution simulation and shelf life (aging) studies.
• Ensure compliance with:
• ISO 11607 (packaging for terminally sterilized medical devices).
• FDA 21 CFR 820 / QSR.
• ISO 13485.
• pplicable ASTM and internal standards.
• uthor and review validation protocols, reports, and technical documentation.

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