Position Title:

Packaging Engineer II Work Location:

Warsaw, Indiana Assignment Duration:

12 months

Work Arrangement:

Onsite Position Summary:

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 our organization requirements.

Key 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 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

Qualification & Experience:

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

Deliverables:

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