Engineer II, Process Engineering Production

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 Engineer II, Process Engineering Production (PEP), is responsible for the roles, within the Process Domain.

As Owner for the following roles, are responsible for the development, description, implementation, training, and monitoring of processes, and, any other tasks assigned to him/her:

• The Developer (Production Process) - define the respective production processes based on the internal customers' requirements. They plan and define work contents and transport concepts. They plan and implement the necessary equipment, the internal flow of materials and any software solutions possibly required for the process to be developed.


• Process Owner (Production Process) - responsible for the development, description, implementation, training, and monitoring of processes assigned.


• Bill of Processes Manager - manage Bills of Processes in SAP or MES workflows for specific products or product groups.

Your Responsibilities

Drive defined plans, within the scope of responsibilities, within the scope of responsibilities on the following subject matters within this job function, in according to the GPVs, by leading and coordinating with multi-department resources.

During Development and Product Transfer phase, together with the interested parties, co-ordinate with relevant parties for Process development and transfer and is accountable on timeline, objective, resources and budget allocated.

• Product Development
  
  
  
  • Create Design Rule (DSR) (Process Development)
  
  
  • Perform feasibility study (manufacturing processes)
  
  
  • Create Manufacturing Flow Chart (MFC)
  
  
  
  


• Develop and Qualify Production Processes by
  
  
  
  • Assign Process Files
  
  
  • Plan, perform and evaluate Operational Qualification (OQ)
  
  
  • Plan, perform and evaluate Performance Qualification (PQ)
  
  
  
  


• Specify Work Plan and Define content of routings/workflows.


• Create the content for their description (FPV)


• First Series
  
  
  
  • Summarize qualification results
  
  
  • Release Process File and Release First Series (ERS)
  
  
  
  


• Release process for serial production

At serial production, drive defined plans, within the scope of responsibilities, in:

• Analyze the processes assigned to them, define their interfaces and boundaries, and determine the requirements for a specification-compliant process result


• Define key performance indicators and analyze them periodically


• Analyze the monitored deviations in the process and initiate Corrective and Preventive Measures (CAPA)


• Responsible for conducting training for the processes

At end serial production,

• The Process Owner (Production Processes) is responsible for Decommission Equipment and cleaning up the relevant process documentation, publishing new document revisions or invalidating documents.


• Additional Role as Bill of Processes Manager also include Inactivate Work Plan (APL) in the SAP-System and Decide on decommissioning.

Your Profile

• Bachelor’s Degree or Diploma in Biomedical, Material, Chemical, Electronics, Mechanical or Industrial Engineering


• Degree holders: at least 3 years of relevant working experience in process / production engineering.


• Diploma holder or equivalent: At least 7 years of relevant working experience in process / production engineering.


• Prior Engineering experience in medical devices industry is preferable.


• Familiar with ISO13485 and GMP.


• Knowledge in SAP and MES is preferable.


• Strong organizational, communication and intercultural skills. 

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: Singapore | Type of contract: Full-Time

Apply now under: www.biotronik.com/careers

Job ID: 62345  | Contact: Human Resources

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.