Staff Engineer Material Engineering (Hybrid, Franklin Lakes, NJ)
Core
Lead industrialization of thermoplastic elastomer (TPE) formulations from lab development to reliable, validated, commercial manufacturing processes for medical devices.
Role type
Staff Engineer, TPE Industrialization and Manufacturing Scale-Up
Builds
Manufacturing processes, process windows, material specifications, and validation strategies for TPE-based medical components.
Domain
Medical Technology / Polymer Science / Manufacturing Engineering
Required skills
TPE formulation development, manufacturing scale-up, DOE and engineering statistics, process validation (IQ/OQ/PQ), root cause analysis, cross-functional technical leadership, material specification creation, supplier technical management, risk-based sampling, measurement system analysis
Preferred skills
Master's or PhD in materials/polymer/chemical engineering, experience with TPV or thermoset elastomers, regulated product development knowledge, sterilization and aging expertise, extractables and leachables knowledge, biocompatibility understanding
Technologies
TPE, TPV, thermoset elastomers, injection molding, sterilization equipment, Gage R&R, regression analysis, process-capability analysis