Principal Process Engineer
Core
Site technical lead for current-state process performance in regulated IVD quality control manufacturing, driving business-as-usual support, capability improvement, and Operational Excellence.
Role type
Principal Process Engineer (Individual Contributor)
Builds
Process capability, yield, throughput, and right-first-time performance in IVD manufacturing
Domain
Life Sciences / Medical Devices / IVD Manufacturing
Required skills
Statistical Process Control (SPC), Process Capability Analysis, Measurement Systems Analysis (MSA), Design of Experiments (DOE), Hypothesis Testing, Root Cause Analysis (DMAIC, 5 Why, Ishikawa, FMEA), GMP compliance, ISO 13485, Validation (IQ/OQ/PQ), Lean Six Sigma, Operational Excellence (Shingo), Cross-functional Stakeholder Management, Technical Coaching
Preferred skills
Lean Six Sigma Green/Black Belt, Shingo-aligned improvement experience, Capacity expansion/CAPEX support, Automation/Technology transfer experience, Data analysis software proficiency
Technologies
Statistical software, Manufacturing Information Systems, Value-stream mapping tools, P&ID software
Responsibilities
Lead structured problem solving for recurring deviations and complex performance issues; Provide technical support for business-as-usual process engineering and automation; Coach engineers and cross-functional teams in statistical methods and Operational Excellence; Lead process characterization and readiness for validation and new product introduction; Maintain process flows, value-stream maps, and process-control documentation; Deploy statistical process control and trend analysis to strengthen process control.
Seniority
Principal, hands-on IC with technical leadership