Principal Quality Engineer, Advanced Catheters & Extrusions
Core
Principal Quality Engineer providing technical leadership for new product development, validation, and commercialization of advanced catheters and extrusions.
Role type
Principal Quality Engineer (Medical Devices)
Builds
Robust medical device products and manufacturing processes for catheters and extrusions
Domain
Medical Devices / Polymer Engineering
Required skills
Test Method Validation (TMV), Process/Equipment Validation (IQ/OQ/PQ), Statistical Analysis, Risk Management, Material Characterization, Technical Documentation, Cross-functional Leadership, Capability Studies
Preferred skills
Class II/III Medical Device Experience, Extrusion/Polymer Manufacturing, Technology Transfer, Project Management, Six Sigma/Lean Certifications
Technologies
IQ/OQ/PQ protocols, Statistical software, Validation tools
Responsibilities
Lead Quality Engineering activities for product and process validation; Apply statistical methods to assess process and product performance; Develop and approve technical documentation including validation protocols; Lead complex quality investigations and CAPA; Provide technical mentorship to engineering teams; Partner cross-functionally to support manufacturing readiness and commercialization.
Seniority
Principal, hands-on IC with mentorship