Job Description Role Summary: Support startup, validation, and stabilization of a catheter production line to achieve target output, quality, and OEE through hands‑on shopfloor engagement and process optimization.
Key Responsibilities - Line Startup: Execute startup plans, support line qualification, and provide shopfloor support during ramp‑up.
- Validation & Process Control: Support OQ/PQ, set process parameters, and ensure Cp/Cpk targets.
- Ramp‑Up & OEE: Drive capacity ramp‑up, monitor OEE, and eliminate losses and bottlenecks.
- Troubleshooting & RCA: Lead root cause analysis (Pareto, Fishbone, 5 Why) for downtime and defects.
- Documentation: Develop SOPs, control plans, and ensure GMP/ISO compliance.
- Collaboration: Work with Production, QA, and Engineering; train operators.
- Continuous Improvement: Drive Kaizen, yield, cycle time, and waste redu...