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Job Description Job Description Job Title:

Packaging Engineer Duration:

12

Months Location:

Warsaw

IN 46580

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 Biomet requirements.

Activities:

a. Review existing DHF documentation related to packaging design, materials, testing, labeling, and validation. b. Identify applicable standards and regulations (e.g., ISO 13485, ISO 11607-1 and

ISO 11607-2, 21 CFR 820, EU MDR

). c. Assess the completeness and compliance of packaging documentation within the DHF. d. Identify gaps related to packaging design inputs/outputs, validation, aging, and labeling. e. Coordinate with quality, regulatory, and project stakeholders to confirm expectations.

Deliverables:

a. Packaging-focused DHF assessment report. b. Packaging gap analysis matrix. c. Regulatory and standards alignment summary. d. Packaging remediation plan and timeline.

Education:

Bachelor's Degree and 1 year 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.