Medical Device Packaging Engineer - Sterile & Regulatory

Katalyst CRO; Buffalo (NY); On-site; USD 85,000 - 125,000; Full time

Job summary

Katalyst CRO is seeking a Medical Device Packaging Engineer to design, develop, validate, and support sterile and non-sterile packaging systems and related manufacturing processes for medical devices. The role ensures packaging solutions meet regulatory, quality, sterilization, and cost requirements while supporting product development, sustaining engineering, and operational excellence.

Responsibilities include packaging design, material selection, process validation (IQ/OQ/PQ), testing, and

Qualifications

• 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.
• Ensures packaging and manufacturing solutions meet regulatory, quality, sterilization, and cost requirements.
• Supports product development, sustaining engineering, and operational excellence.

Responsibilities

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

Job description

Katalyst CRO is seeking a Medical Device Packaging Engineer to design, develop, validate, and support sterile and non-sterile packaging systems and related manufacturing processes for medical devices. The role ensures packaging solutions meet regulatory, quality, sterilization, and cost requirements while supporting product development, sustaining engineering, and operational excellence.

Responsibilities include packaging design, material selection, process validation (IQ/OQ/PQ), testing, and