Lausanne, Vaud, Switzerland
• Improve the reliability of the tester. • Improve productivity of the tester. • Resolve tester related product issues. Coordinates in local and assist the global team in such kind of issues. • Implement and control changes related to new products, software release, and improvements, applying global strategies. • Provide proposals and expertise to Manufacturing Engineering. • Provide within scope of a global team, inputs and interfaces with test development team Specialties: Word, Excel, Access, SQL language, Analytical Troubleshooting, TPM, DOE, Gage R&R Statistics
Hold the responsibility to evaluate, characterize, qualify and validate product/process/line in assigned scope of processes. Evaluate, characterize, qualify and validate major manufacturing and product improvements within performance objectives Align manufacturing processes to all global sites by contributing to the global process development and qualification protocols and execution. Train Technical support of Implantable Device Lead/participate to projects managed through PMO. Support Implantable Devices tasks (technical support, non-conformity management, continuous improvement). Support/Lead Operation Excellence initiatives among high volume facilities In collaboration with Development Workflow, provide feedbacks to Design and evaluate new Process/Products According to competencies, be the specific process referent Qualifications HES/EPF Engineer or equivalent Position usually requires minimum five years of experience and an advanced specialized engineering degree, typically referred to as a technical expert. Excellent English (oral and written). Experience Desktop applications, analytical tools, presentations, analytic tools (Medstats), charts, reporting. Team leadership skills: requires two to three years of experience in project/team management on medium scope or background in product or process development projects. Experience on Lean manufacturing 3 years minimum experience in Quality Systems Regulations, and Quality System covering process controls, non-conforming product and document controls. 3 years minimum experience to Quality (compliance, product analysis, CAPA), operational metrics (FRY, FAPC, TPCT, capacity, investment return) and Process metrics (trends, yields). In-depth experience in application of validation protocols and product acceptance testing.
• Tester Reliability and effectiveness: Lead local technology effort and coordinates activities related to the specified test system. Identify impactors which affects equipment productivity/downtime and propose and implement solutions to measure and improve reliability. Use product/self test data and statistical process control tools to improve the reliability. Coordinate, plan, perform, document the changes internally and globally. Comply to standardization guidelines and common implementation standard from global team. Acquire and install tester capacity and capability required Identify personal need for training based on future transfers/products • Product tester interface: Identify an resolve the Equipment related product failure. Work with production team to identify and resolve the key product impactors (Yield analysis, Pareto of equipment related product failures). • Troubleshooting guide : Create and maintain the troubleshooting guide to help line technician.
During those five years, I trained myself on different test equipments, LabView softwares, Analytical Troubleshooting methods, Projects management. I participated and was responsible to release for Production use 5 KuKa Robotic Cells, new NGT test systems, Post Sterilization testers and the Automated Patient Alert test system. In this position, all the qualifications, software or hardware upgrades were successfully implemented. Equipments reliability and effectiveness were continuously improved. Total Productive Maintenace was one of the method used to achieve downtime goals.
In this position I have been responsible to transfer test systems equipments from Netherland to Switzerland. I had to create the "POD" procedures to have operators running the testers properly and test products accordingly specifications. I took the responsability of the Patient Alert, ATS, NGT and Post Sterilization test systems.