AL
Packaging Engineer
Artech LLC
- 🇵🇱 Poland | 🇺🇸 United States
- On-site
- 9 hours ago
9 hours ago
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.
Packaging Engineer · Artech LLC