Engineer II, R&D, Packaging Test Lab
Core
Lead test method development, equipment qualification, process optimization, and digital transformation for sterile and non-sterile medical device packaging systems.
Role type
Senior IC R&D Packaging Test Lab Engineer
Builds
Validated packaging testing solutions for cardiovascular medical devices
Domain
Medical device manufacturing / Quality assurance / Packaging engineering
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Test method development, Equipment qualification (IQ/OQ/PQ), Process optimization, Statistical analysis, Technical writing, Laboratory process management, Supplier quality management, Team leadership, Root cause investigation, Regulatory compliance knowledge
Preferred skills
Medical device packaging validation, Automation and scripting, LIMS usage, Data analytics tools (Minitab, Power BI), Digital transformation initiatives, Environmental conditioning testing, Sterilization validation support
Technologies
Minitab, Excel, Power BI, Power Platform, LIMS
Responsibilities
Design and execute package testing and validation activities, Develop and improve test methods and work instructions, Analyze test data to identify trends and anomalies, Lead equipment qualification and laboratory investigations, Drive laboratory automation and workflow optimization, Provide technical direction and training to technicians
Seniority
Mid-level, hands-on IC
