Packaging DHF Remediation & Regulatory Compliance Engineer

Fusion Life Sciences Technologies LLC; Warsaw (IN); Sur place; USD 70 000 - 90 000; Plein temps

Résumé du poste

Fusion Life Sciences Technologies LLC is seeking a Packaging Engineer to support packaging DHF remediation and EOL support. This role focuses on establishing baseline packaging DHF content and identifying gaps relative to regulatory and client requirements.

You will review DHF documentation related to packaging design, materials, testing, labeling, and validation; assess completeness of packaging documentation; coordinate with quality, regulatory, and project stakeholders to align on

Qualifications

• Bachelor's Degree or higher with 1 year of relevant experience (or equivalent)
• Experience with DHF in packaging contexts is preferred
• Knowledge of ISO 13485, ISO 11607, 21 CFR 820, EU MDR is favorable

Responsabilités

• Review existing DHF documentation related to packaging design, materials, testing, labeling, and validation.
• Identify applicable standards and regulations (e.g., ISO 13485, ISO 11607-1/2, 21 CFR 820, EU MDR).
• Assess completeness and compliance of packaging documentation within the DHF.
• Identify gaps related to packaging design inputs/outputs, validation, aging, and labeling.
• Coordinate with quality, regulatory, and project stakeholders to confirm expectations

Connaissances

Packaging DHF assessment report

Packaging gap analysis matrix

Regulatory alignment summary

Remediation plan and timeline

Formation

Bachelor's degree in relevant field

Associate's degree

High school diploma or equivalent

Description du poste

Fusion Life Sciences Technologies LLC is seeking a Packaging Engineer to support packaging DHF remediation and EOL support. This role focuses on establishing baseline packaging DHF content and identifying gaps relative to regulatory and client requirements.

You will review DHF documentation related to packaging design, materials, testing, labeling, and validation; assess completeness of packaging documentation; coordinate with quality, regulatory, and project stakeholders to align on