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

 
 
At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws.This position's pay range is $45.00/hr - $55.00/hr.