Senior, Packaging Design Engineer
Core
Design, develop, verify, and launch mechanical packaging systems for sterile and non-sterile medical devices including surgical instruments and capital equipment.
Role type
Senior IC mechanical packaging design engineer
Builds
Primary, secondary, and tertiary packaging components (trays, pouches, cartons) for new product introductions and sustaining engineering
Domain
Medical device manufacturing and regulatory compliance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
packaging dynamics, sterilization process compatibility (EtO, Gamma), packaging validation (CFR 820, ISO 11607), tolerance stack analysis, structural FEA, process simulation, material selection, CAD (Solidworks), project management
Preferred skills
thermoforming (FFS), pouch sealing, high-volume manufacturing experience
Technologies
Solidworks, ISTA, ASTM
Responsibilities
Lead design and verification of complex packaging systems; execute comprehensive packaging testing protocols; develop full-scale prototypes; interface with suppliers for component qualification; collaborate with manufacturing to create tooling and assembly processes; ensure regulatory compliance for FDA and ISO standards; mentor junior engineers; perform root cause analysis and CAPA for design non-conformances
Seniority
Senior, hands-on IC with mentorship responsibilities