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 :
1. Provides engineering support, including equipment/tools troubleshooting, training, upgrades, efficiency and safety improvements, etc.
2. Through the use of data, identifies and implements process parameters setup and change s that will improve quality and productivity
3. Supports new product launches and executes process changes related to: methods, parameters and material changes
4. Originates and investigates quality events using RCA
5. Writes and executes regulatory documentation including Operational Qualification (OQ) and Performance Qualification (PQ)
6. Leads the installation and validation of equipment
7. Builds internal/external system to support replication of best practices and lessons learned
8. Tracks equipment downtime, identify bottleneck, and report downtime appropriately
9. Implements and maintains std operations along all the production lines: layout plan, process improvement plan and execution, equipment capacity estimate
10. Supervises the implementation of Lean Management techniques in all the areas of the organization
11. Analyzes and identifies potential areas of processes improvement
12. 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:
13. Knowledge and understanding of PLC/SCADA/HMI systems
14. Knowledge of industrial control systems
15. Knowledge of smart camera vision system
16. Knowledge of plastic parts assembly : welding (laser, ultrasonic), adhesive and mechanical fixing
17. Good understanding of the main process validation methodologies (process data analysis for the best parameters identification, set up and optimization)
18. Ability to apply fundamental engineering principles to process understanding, problem solving and process improvement
19. Strong Root Cause Analysis understanding
20. Lean Six Sigma Green Belt – an advantage
21. Expertise in FMEA’s
Language:
English level B1
Career with a purposeWe offer an opportunity to create and deliver treatments that save and change lives for the better. We’ll support your ongoing development. And you’ll be part of a dedicated team of people who inspire each other to create the best possible healthcare outcomes each and every day. Inclusion and diversityJoining Fresenius Medical Care means becoming part of a team that values diversity. We embrace the wealth of different backgrounds, cultures, experiences and opinions that make up our workforce and strive to create an inclusive atmosphere in which all our employees feel valued. StabilityDeveloping innovative products and continuously improving our renal therapies made us the clear market leader in the production of hemodialysis machines, with sustainable, profitable growth. This position provides our 125000 employees with the stability and security they need to help improve the lives of our patients. Learning and developmentWe offer participation in programs at world-class business schools, leadership development, regular training for our nurses, health care professionals and manufacturing staff and digital access to high-quality educational content for all employees worldwide 24/7. Local benefitsOur employees enjoy both local and global opportunities for growth and personal fulfilment. We offer local benefits designed to suit the requirements of the respective country and place of work to create ideal conditions everywhere. Work-life balanceWe want to empower people to deliver better care. Therefore, we promote a better work-life balance through flexible working hours, part-time models, the possibility to work from home, and more.