Molding Engineer (Medical devices)
Core
Develop and validate injection molding processes for medical device manufacturing, ensuring manufacturability and quality compliance.
Role type
Injection Molding Process Engineer
Builds
Medical device components via injection molding
Domain
Medical devices / Manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
injection molding process development, IQ/OQ/PQ validation, DOE interpretation, statistical process analysis, GD&T, ISO 13485, FDA 21 CFR 820, low pressure molding, auxiliary equipment handling
Preferred skills
cpk/ppk, GR&R, Six Sigma, Lean, process control
Technologies
injection molding machines, dryers, chillers, hot runners
Responsibilities
Develop injection molding processes using scientific methodologies, validate molds and work cells through IQ/OQ/PQ, document molding processes and troubleshooting, support production troubleshooting and process improvement, define designs for manufacturability, implement statistical process analysis, train production personnel on new technology transfer
Seniority
Mid-level, hands-on IC