Packaging Engineer
Core
Design, develop, validate, and implement packaging systems for medical devices to ensure product protection and regulatory compliance.
Role type
Packaging Engineer (Medical Devices)
Builds
Primary, secondary, and tertiary packaging systems for medical device products
Domain
Medical Technology / Healthcare Manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Packaging design and development, Validation protocols (IQ/OQ/PQ), FDA regulations (21 CFR Part 820), ISO 13485, ISO 11607, GMP, Risk assessment (FMEA), Root cause analysis, CAPA, Lean Manufacturing, Six Sigma, CAD software, ERP systems (SAP/Oracle), Statistical analysis
Preferred skills
Bilingual (English/Spanish), Statistical software (Minitab), Packaging equipment automation
Technologies
CAD software, SAP, Oracle, Minitab
Responsibilities
Design and develop packaging systems for medical devices, Execute packaging validation protocols, Support new product introductions and packaging changes, Investigate packaging quality issues and lead root cause analyses, Collaborate with cross-functional teams on audits and change controls, Drive cost reduction and process improvement initiatives
Seniority
Mid-level, hands-on IC