Packaging Engineer

Katalyst CRO; Buffalo (NY); On-site; USD 70,000 - 90,000; Full time

Job summary

Katalyst CRO is seeking a Medical Device Packaging Engineer to be responsible for the design, development, and validation of packaging systems for medical devices. This role encompasses ensuring that packaging solutions meet regulatory, quality, and compliance requirements.

The ideal candidate will lead efforts in selecting materials, qualifying packaging systems, and optimizing manufacturing processes while supporting product development and operational excellence.

Qualifications

• Experience in designing and developing packaging systems for medical devices.
• Knowledge of regulatory standards like ISO and FDA.
• Proficiency in driving cost reduction and efficiency improvements.

Responsibilities

• Design and develop packaging systems for medical devices.
• Select and qualify packaging materials.
• Lead packaging and manufacturing validations.
• Ensure compliance with regulatory standards.

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.

Responsibilities

Packaging & Manufacturing Engineering

• 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.

Validation & Regulatory 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.
• Applicable ASTM and internal standards.
• Author and review validation protocols, reports, and technical documentation.