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Production Engineer Ii, CRM

2 weeks ago

Singapore BIOTRONIK Full time

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.

**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 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.

**Technical Competency**

**Statistical skills**:

- 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.

**Continuous Improvement Project Management**:

- 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.

**Sterilization**
- Understanding of types of EO Sterilization processes for medical devices and their operating principles.
- Demonstrate ability to develop EO Sterilization processes’ parameters.
- Experience with 3M sterilization equipment desirable
- Basic knowledge of ISO 11135:2014

**Your Profile**
- Bachelor’s Degree or Diploma in Biomedical, Material, Chemical, Electronics, Mechanical or Industrial Engineering, or equivalent.
- Degree holders: at least 3 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.
- Use of statistic in root cause analysis with six-sigma Greenbelt will be advantages.
- Experience with manufacturing processes and methods, eg. Lean, Kaizen, Kanban and other advanced manufacturing methodologies, tools and concepts will be advantages.
- Familiar with ISO13485 and GMP.
- Basic 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: 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.