• 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).
  
  

• 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.
  
  

• 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.

• 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.

• Implement concepts of Poka Yoke, SMED into assembly tooling and fixtures.
• Utilize 5S, 7-Mudas, Kaizen, Process flow, Spaghetti diagrams for production flow optimizations.

• 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.

• 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).

• Bachelor’s Degree or Diploma in Biomedical, Material, Chemical, Electronics, Mechanical or Industrial Engineering;
• Degree holders: at least 2 years of relevant working experience in process / production engineering.
• Diploma holder or equivalent: At least 8 years of relevant working experience in process / production engineering.
• Prior Engineering experience in medical devices industry is preferable.
• Familiar with ISO13485 and GMP.
• Basic knowledge in SAP and MES is preferable.
• Strong organizational, communication and intercultural skills.

• being encouraged to think and act entrepreneurially
• working in global teams and projects
• developing yourself professionally