Production Engineer II, CRM

at  BIOTRONIK

Production Engineer II, CRM
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.

WHAT WE OFFER

• being encouraged to think and act entrepreneurially
• working in global teams and projects
• developing yourself professionally
  Are you interested? Please apply online through our application management system! We are looking forward to welcoming you.
  Location: XXX | Working hours: Full-time | Type of contract: Unlimited
  Job ID: 58072 | Contact: TU Recruiting | Tel. XXX
  We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, sexual orientation, gender identity or expression, national origin, disability status, protected veteran status, genetic information, or any other characteristic protected by law

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 process, plan and co-ordinate with relevant parties for Process transfer and is accountable on timeline and objective.
• Coordinate equipment procurement activities in liaising with vendors from design input stage up to factory acceptance test (FAT).
• Process Develop for equipment procurement locally.
• 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.