Process Engineer
Core
Manufacturing process improvement focusing on yield, efficiency, validation, and standardization of operating procedures to develop a world-class medical device manufacturing plant.
Role type
Manufacturing Process Engineer
Builds
Medical device production lines (insulin pumps, subcutaneous drug delivery systems)
Domain
Medical Devices / Biotechnology / Manufacturing
Deliverable
production ML models | product features | dashboards & analysis | infrastructure
Required skills
Process validation, DMAIC, Six Sigma, Lean manufacturing, Statistical analysis, Machine-to-machine process analysis, Material variation evaluation, MES optimization, Work instruction creation, Cross-functional troubleshooting, Cleanroom operations
Preferred skills
cGMP guidelines, ISO 13485, FDA 21 CFR 820, CAD, ERP/MES/Spotfire/PowerBI, Automated equipment setup/debugging, Laser/heat/ultrasonic welding, ESD-sensitive device handling, Start-up environment experience, pFMEA, Quality Control Plan
Technologies
MES, Spotfire, PowerBI, CAD, ERP systems
Responsibilities
Implement validation for NPI and process changes, Conduct engineering studies to analyze process data, Drive continuous improvement via DMAIC, Optimize machine performance through process analysis, Certify operators for TPM and competence, Evaluate material variation against process performance, Optimize material flow and MES usage, Create and review manufacturing scorecards and dashboards, Update work instructions, Troubleshoot issues in cross-functional teams, Follow up on production issues 24/7
Seniority
Mid-level, hands-on IC
