Packaging Engineer
Core
Ensure medical device packaging activities comply with GMP, ISO 13485/11607, and regulatory standards through validation, testing, and documentation.
Role type
Medical device packaging engineer
Builds
Validated packaging systems and processes for medical devices
Domain
Healthcare / Medical Device Manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
ISO 11607 knowledge, GMP compliance, statistical analysis (Minitab), CAD (Siemens Solid Edge), packaging validation protocols, regulatory standards interpretation, packaging testing equipment operation
Preferred skills
Risk management, data integrity, cross-functional collaboration
Technologies
Minitab, Siemens Solid Edge, EXACT ERP, seal strength testers, burst testers, dye penetration testers
Responsibilities
Plan and execute packaging tests per ISO 11607; develop validation protocols and test plans; analyze validation data; improve packaging workflows and tools; maintain QMS documentation; collaborate with engineering and quality teams
Seniority
Mid-level, hands-on IC