Engineer II, Process Engineering Production

BIOTRONIK; Singapore; On-site; SGD 90,000 - 120,000; Full time

Benefits offered by this job

Global project teams

Professional development

Job summary

BIOTRONIK, based in Berlin and represented globally, seeks an Engineer II, Process Engineering Production in Singapore. You will own production processes, develop and transfer them, and manage SAP/MES workflows across product families, ensuring quality and alignment with GMP/ISOs.

The role emphasizes cross-department collaboration, process qualification, and decommissioning tasks at serial production, with a focus on delivering compliant, efficient processes.

Qualifications

• Bachelor’s Degree or Diploma in Biomedical, Materials, 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.

Responsibilities

• Drive defined plans, within the scope of responsibilities, on the subject matters within this job function.
• Coordinate with relevant parties for process development and transfer during Development and Product Transfer phase.
• Develop and qualify production processes by assigning process files and planning OQ/PQ.

Skills

Organizational skills

Communication

Intercultural skills

Education

Bachelor’s Degree or Diploma in Biomedical/Materials/Engineering

3+ years experience in process/production engineering

Tools

SAP

MES

Job description

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 transferand 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

Location: Singapore | Type of contract: Full-Time

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.