Process Engineer Finished Product & Sterilization

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

·        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

STERILIZATION PROCESS EO, EBEAM, STEAM

·        Writes and reviews procedures concerning sterilization process and its validation tests   

·        Schedules validation and re-validation programs issuing the relative Validation Plan and Reports

·        Evaluates and approves validation protocols issued by external sterilization suppliers

·        Analyzes process or validation deviations and identifies corrective actions in agreement with QA

·        Checks the application of validated sterilization cycles in case of new product / change

·        Evaluates and analyzes any possible equipment change implemented by supplier by means of relative documentation checking

·        Receives/Performs the periodical inspection of sterilization norms and regulations and plans the purchasing of new revisions by issuing the gap analysis between versions

·        Provides training concerning sterilization process

·        Analyzes and identifies potential areas of improvement for sterilization process / documentation by attending the “best practices sharing plant to plant” meetings.

• Master degree or similar education level in engineering disciplines
• At least 3 years of experience in similar positions

Technical knowledge, special trainings:

• Good knowledge and understanding of PLC/SCADA/HMI systems
• Knowledge of industrial control systems
• Good Knowledge of smart camera vision system
• Programming of PLCs, HMIs and SCADA – an advantage
• Good 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
• Knowledge of sterilizations process and relative norms

Important personal qualities:

• Interpersonal savvy
• Collaborates
• Resourcefulness
• Tech Savvy
• Action oriented
• Plans and aligns
• Optimize work processes
• Ensures accountability
• Drives results
• Instills trust
• Nimble learning

Permanent contract in a multinational context

Smart Working