Principal Process Engineer
Core
Site technical lead for current-state process performance in regulated IVD quality control manufacturing, driving business-as-usual support, capability control, and continuous improvement.
Role type
Principal Process Engineer (Individual Contributor)
Builds
Process capability, yield, throughput, and right-first-time performance in IVD manufacturing
Domain
Regulated medical device/diagnostics (IVD) manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
DMAIC, A3, 5 Why, Ishikawa, FMEA, risk-based root cause analysis, SPC, process capability analysis, MSA, DOE, hypothesis testing, statistical thinking, process characterization, commissioning, IQ/OQ/PQ, GMP, ISO 13485, change control, risk management, value-stream mapping, P&IDs
Preferred skills
Lean Six Sigma Green/Black Belt, Shingo principles, Operational Excellence, capacity expansion, CAPEX, automation, new product introduction, technology transfer, statistical software
Technologies
None explicitly listed beyond general statistical and data-analysis tools
Responsibilities
Provide timely technical support and measurable process-performance improvement for critical manufacturing processes; Lead site-wide structured problem solving for recurring deviations and complex performance issues; Balance hands-on technical support with strategic process-control and continuous-improvement priorities; Partner cross-functionally with Operations, Quality, Validation, Engineering, Supply Chain, Finance, Regulatory, and site leadership; Prepare and communicate clear technical assessments, investigation outputs, risk evaluations, and process-performance reports; Coach engineers and cross-functional teams in process engineering, statistical methods, and Operational Excellence practices; Lead process characterisation and readiness for validation, new product introduction, and technology transfer; Deploy and coach statistical process control, process capability analysis, and trend analysis to strengthen process control
Seniority
Principal, hands-on IC with technical leadership and coaching
