Packaging Engineer

Duties:

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.

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 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

Skills:

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 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

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