Senior Production Engineer (HV06)

Job Detail

As one of the world´s leading manufacturers of cardio- and endovascular medical devices, BIOTRONIK is headquartered in Berlin, Germany, and represented in over 100 countries by its global workforce. The work of our committed, highly specialized, exceptionally skilled employees results in crucial advancements in the world of cardiology and changes the lives of patients every day. The Production Engineer, as Process Owners (Production Process) are responsible for the development, description, implementation, training, and monitoring of processes assigned to them. Your Responsibilities Analyzing processes assigned, define the processes’ interfaces and boundaries, and determine the requirements for a specification-compliant process result through perform and document process validations or re-validations including IQ, OQ and PQ. Develop the process steps together with the interested parties: Define content of routings/workflows. Create the content for their description (FPV). During product transfer: Taking charge of own assigned processes, plan and co-ordinate with relevant parties for Process transfer and is accountable on timeline and objectives Derive acceptance criteria for process target quantities. Prepare production transfer (ERS). Prove achievement of the process target quantity. Release process for serial production. At serial production, drive defined plans: Monitor key performance indicators, analyze them periodically, monitored deviations in the process and initiate corrective actions; Conduct continuous improvements for operating performance through yield improvement, cycle-time optimization, waste reduction and productivity improvements; Monitor climate conditions/process media and work with relevant parties to take corrective actions for deviation or abnormality. Statistical skills: Optimize of parameters with DOE. Identify area of need for Measurement System Analysis, plan and execute MSA, analysis the collected data and derive corrective actions. Conclusion of Hypothesis testing with statistical means. Identify Special and Common cause variables and take appropriate actions to address them. Define and determine the process capability of respective processes. Lean Manufacturing: Implement concepts of Poka Yoke, SMED into assembly tooling and fixtures. Utilize 5S, 7-Mudas, Kaizen, Process flow, Spaghetti diagrams for production flow optimizations. Plan, develop and improve Kanban system for production Line (include supermarket and milk-run). Continuous Improvement Project Management: Able to Lead project teams in Continuous Improvement Projects (CIPs) in systematically approach of problem solving at 6-Sigma Green belt or equivalent level. Able to Lead, co-ordinate and use in FMEA / PRA in Continuous Improvement Projects (CIPs). Utilize Ishikawa, PDCA, A3 Problem Solving, in day to day production activities / improvements. Laser Technology: Laser parameter process development: Develop the pulse shape, power, focus height of a new laser system in Leads production. Metallography: Perform and analysis of laser welded parts for microstructures, intermetallic, mechanical properties, eg, with high magnification microscopes or C-SEM (cross-sectional scanning electron microscopy). Demonstrate the understanding of light's technical applications over the whole spectrum and the relation to Laser technology. Understanding of types of laser and their operating principles, and the use of such Laser in Leads production (eg. Laser welding and Laser marking, etching, and engraving).