What are the responsibilities and job description for the Packaging Development Engineer position at Fusion Life Sciences Technologies LLC?
Packaging Engineer
Warsaw, IN(Onsite)
12 Months
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 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:
Deliverables:
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