What are the responsibilities and job description for the Medical Device Packaging Engineer position at SPECTRAFORCE?
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
Applicant Notices & Disclaimers
- For information on benefits, equal opportunity employment, and location-specific applicant notices, click here
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.
Salary : $55 - $55