Packaging Engineer 3
Core
Design, develop, and qualify packaging systems for sterile and non-sterile medical devices to ensure product integrity, sterility, and regulatory compliance.
Role type
Senior IC packaging engineer (medical devices)
Builds
Primary, secondary, and tertiary packaging solutions for dialysis disposables and machines
Domain
Healthcare / Medical Devices / Sterile Manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Packaging design and development, Material selection and qualification, Validation planning and execution (ISO 11607), Regulatory compliance (FDA 21 CFR 820, ISO 13485, EU MDR), Risk management (ISO 14971), Root cause analysis, Supplier management, Technical documentation
Preferred skills
Lean / Six Sigma, Continuous improvement, Sterilization compatibility studies (EtO, gamma, e-beam, steam), Cleanroom operations
Technologies
Heat sealers, Pouching systems, Tray sealers, Distribution simulation tools
Responsibilities
Design and develop packaging solutions for medical devices, Execute packaging validations and seal integrity testing, Ensure compliance with global regulatory requirements, Support packaging equipment and line setups, Lead investigations into packaging nonconformances, Collaborate cross-functionally with R&D, Quality, and Supply Chain
Seniority
Mid-Senior, hands-on IC
