Packaging Development Engineer

Fusion Life Sciences Technologies LLC; Warsaw (IN); On-site; USD 70,000 - 90,000; Full time

Job summary

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

Responsibilities

• 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

Skills

Packaging DHF assessment report

Packaging gap analysis matrix

Regulatory alignment summary

Remediation plan and timeline

Education

Bachelor's degree in relevant field

Associate's degree

High school diploma or equivalent

Job description

Packaging Engineer supporting packaging DHF Remediation and EOL support

Objective: Establish a baseline understanding of packaging-related DHF content and identify gaps relative to regulatory and "Client" requirements.

Activities:

• 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 and ISO 11607-2, 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

Skills:

• Packaging-focused DHF assessment report
• Packaging gap analysis matrix
• Regulatory and standards alignment summary
• Packaging remediation plan and timeline

Education:

Bachelor's Degree and 1 years of relevant experience, or Associate's Degree and 3 years of relevant experience, or High School Diploma or Equivalent and 5 years of relevant experience