About the role
Focus on sterile barrier packaging design, ASTM/ISTA/ISO 11607 testing, design controls, regulatory compliance (ISO 13485, EU MDR/FDA), and cross-functional project execution.
Responsibilities
- Experience in sterile barrier packaging design and ASTM/ISTA/ISO 11607 testing.
- Proven experience in design controls, DV, shelf-life and transportation validation, change control, and regulatory compliance.
- Skilled in root cause analysis and supplier and manufacturing interface.
- Cross-functional project execution to support compliant product launches and sustaining activities.
- Experience in change management and Design Quality.
Full description
Job Description:
Experience Required: 5+ Years
Packaging R&D Engineer with strong expertise in sterile barrier packaging design and ASTM/ISTA/ISO 11607 testing.
Proven experience in design controls, DV, shelf‑life and transportation validation, change control, and regulatory compliance (ISO 13485, EU MDR/FDA).
Skilled in root cause analysis, supplier and manufacturing interface, and cross‑functional project execution to support compliant product launches and sustaining activities
Experience in the change management and Design Quality