Medical Device Packaging Engineer

Experience: 6 8 Years

Location: Bangalore

Skill: EIS Production Engineering | Product Packaging

• contract role

Role: Medical Device Packaging Engineer

We are looking for an experienced Medical Device Packaging Engineer to design, develop, test, and validate packaging systems for medical devices, ensuring product protection, sterility, regulatory compliance, and transportation durability.

Key Responsibilities

• Design and develop primary, secondary, and tertiary packaging, including sterile barrier systems, trays, pouches, cartons, and shippers.
• Prepare and maintain DHF, design verification/validation protocols, test reports, DFMEA and PFMEA documentation.
• Execute packaging validation in compliance with ISO 11607-1 and ISO 11607-2.
• Plan and perform ISTA 1, ISTA 2, and ISTA 3A transit simulation and package integrity testing.
• Conduct vibration, drop, compression, incline impact, and environmental conditioning tests.
• Work with R&D and Sterilization teams to ensure packaging compatibility with Gamma, E-beam, and Steam sterilization.
• Investigate packaging failures and transportation damage, perform root-cause analysis, and implement corrective actions.
• Ensure packaging designs comply with FDA, ISO 13485, ASTM, and applicable industry standards.
• Collaborate with suppliers on packaging materials, qualification, cost optimization, and quality improvement.

Mandatory Skills

• Medical Device Packaging Design & Development
• ISO 11607-1 / ISO 11607-2
• ISTA 1 / ISTA 2 / ISTA 3A
• Packaging Validation & Design Verification
• Sterile Barrier Systems
• Transit Simulation & Package Integrity Testing
• DFMEA / PFMEA and Design Controls
• Packaging Materials: Corrugated, Cartons, Thermoformed Plastics, Flexible Films, EPS/EPE/EPP
• FDA / ISO 13485 compliance

Qualification

Bachelor s degree in Packaging Engineering, Packaging Science, Mechanical Engineering, Materials Engineering , or a related discipline.

Preferred Experience Experience in medical devices, healthcare products, regulated manufacturing, CPG, electronics, or e-commerce packaging with hands-on packaging design and standardized distribution testing. eligible candidates send resume to: [email protected] , and fell free to share !