Process Engineer Automation

Goal of function:

Designs, implements and optimizes production processes, improving efficiency, reducing costs and ensuring compliance with current regulations for the production of medical devices.

Main tasks:

• Provides engineering support, including equipment/tools troubleshooting, training, upgrades, efficiency and safety improvements, etc.

• Through the use of data, identifies and implements process parameters setup and changes that will improve quality and productivity

• Supports new product launches and executes process changes related to: methods, parameters and material changes

• Originates and investigates quality events using RCA

• Writes and executes regulatory documentation including Operational Qualification (OQ) and Performance Qualification (PQ)

• Leads the installation and validation of equipment

• Builds internal/external system to support replication of best practices and lessons learned

• Tracks equipment downtime, identify bottleneck, and report downtime appropriately

• Implements and maintains std operations along all the production lines: layout plan, process improvement plan and execution, equipment capacity estimate

• Supervises the implementation of Lean Management techniques in all the areas of the organization

• Analyzes and identifies potential areas of processes improvement

• Manages documentation and lean outcomes control, supervises improvement actions

Requirements:

Required training and education:

Master degree or similar education level in engineering disciplines

Required professional experience:

At least 3 years of experience in similar positions

Technical knowledge:

• Knowledge and understanding of PLC/SCADA/HMI systems

• Knowledge of industrial control systems

• Knowledge of smart camera vision system

• Knowledge of plastic parts assembly: welding (laser, ultrasonic), adhesive and mechanical fixing

• Good understanding of the main process validation methodologies (process data analysis for the best parameters identification, set up and optimization)

• Ability to apply fundamental engineering principles to process understanding, problem solving and process improvement

• Strong Root Cause Analysis understanding

• Lean Six Sigma Green Belt – an advantage

• Expertise in FMEA’s

Language:

English level B1