Job Description 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. Show more Skills
Code of Federal Regulationsunmatched
Cost Controlunmatched
FDA (Food and Drug Administration)unmatched
ISO (International Organization for Standardization)unmatched
Maintain Complianceunmatched
Manufacturingunmatched
Manufacturing Engineeringunmatched
Manufacturing Requirementsunmatched
Manufacturing Systemsunmatched
Manufacturing/Industrial Processesunmatched
Medical Equipmentunmatched
Process Improvementunmatched
Process Validationunmatched
Product Developmentunmatched
Product Packagingunmatched
Product Supportunmatched
Quality Managementunmatched
Quality System Requirements (QSR)unmatched
Regulatory Complianceunmatched
Simulationunmatched
Sterilizationunmatched
Technical Writingunmatched
Validation Planunmatched
Writing Skillsunmatched
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