Principal Engineer, OpEx
Core
Leading continuous improvement initiatives across manufacturing and operational processes to enhance efficiency, reduce waste, and improve product quality in the medical device industry.
Role type
Principal Operational Excellence Engineer
Builds
Operational efficiency and product quality improvements
Domain
Medical device manufacturing / Operational Excellence
Required skills
Lean Manufacturing, Six Sigma, process engineering, project management, data analysis, regulatory compliance (FDA/ISO), training and mentorship
Preferred skills
Black Belt or Master Black Belt certification, statistical analysis software (Minitab, JMP), cross-functional team leadership
Technologies
Lean Daily Management System, Minitab, JMP
Responsibilities
Lead and drive continuous improvement initiatives, manage OpEx projects from inception to completion, analyze operational data and performance metrics, provide training and mentorship on Lean methodologies, ensure compliance with regulatory standards (FDA, ISO 13485), collaborate with cross-functional teams
Seniority
Principal, hands-on IC with strategic leadership