Assembly Automation | Process Development
Current1. Working as Technical PM in the process development team to lead and develop Automated systems/Assembly lines for Medical Devices.2. Cross-functional leader, interacting with various departments, internal stakeholders, and suppliers 3. Establish and maintain appropriate project governance to ensure communication, flow of information, and documentation within the project.4. Responsible for project deliverables, schedule, and management reporting. 5. Review the schedule with the supplier and project team. 6. Organize project kick-off, concept review, design review, and project status update meeting. 7. Follow up on action items of the project meeting. 8. Proactively identify and manage the risks of the project and escalate according to the project escalation level. 9. Follow company procedure to improve and author User Requirement Specification of process equipment for purchasing and to ensure content covers technical necessity and general specification to meet medical device manufacturer's industrial criteria. 10. Ensure that machine specifications are correct, complete, feasible, and efficient. 11. Monitor and ensure engineering design and documentation are on time and complete. 12. Executing the design review with external Fully Automated Assembly Machine suppliers for process layout design, process optimization, and equipment development. 13. Suggest or provide solutions when a deviation occurs. 14. General technical methodology/proposal alignment with relevant stakeholder departments (Risk Department, Validation Department, Project Management Department, Quality Department).15. Review Documentation such as Functional Specification (FS), Hardware & Software Design Specification,16. Support the complete project lifecycle such as Process Integration, FAT and SAT with supplier. 17. Review and schedule machine tests and review test results.18. Responsible to follow the principle of GMPs