Production Engineer, CRM

Production Engineer, 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 CRM develops and improves administration and coordination of production engineering projects, policies, processes, methods and procedures designed to improve operating performance, reduce waste and delays and otherwise promote cost reductions on a company-wide basis. He/she will be supporting product transfers and be responsible for the process transfer within the transfer project. Furthermore he/she will introduce process optimizations. The Production Engineer CRM establishes and maintains effective communication with employees, manufacturing and quality department, management and other stakeholders.

**Your Responsibilities**
- Evaluate and improve manufacturing processes and reduce costs using knowledge of manufacturing processes, tooling and production equipment, assembly methods or quality control standards
- Conduct time-studies in order to improve operating performance
- Determine root causes of failures using statistical methods and recommend and implement changes for problem solving and process optimizations
- Provide technical expertise or support related to manufacturing
- Train production personnel in new or existing methods
- Design layout of equipment or workspaces or optimize the production flow to achieve maximum efficiency
- Prepare reports by collecting, analyzing and summarizing information and trends
- Analyze statistical data and product specifications to determine standards and establish quality and reliability objectives of finished products together with the manufacturing and quality department
- Take ownership and responsibility for CAPA-Activities as well as change requests
- Develop new methods and processes and support product development activities
- Prepare and take responsibility for documentation for new manufacturing processes or engineering procedures
- Risk assessment of production processes in collaboration with Product Development and Quality Department
- Create requirement specifications of equipment including cost-effectiveness study and validation plans for the machine and process validation
- Perform and document process validations or re-validations including IQ, OQ and PQ
- Design testing methods and test finished products or process capabilities to establish standards or validate process requirements
- Analyze technology, resource needs and market demand, to plan and assess the feasibility of projects
- Manage projects independently and coordinate the implementation
- Consult vendors, staff and management personnel regarding purchases, procedures, product/process specifications, manufacturing capabilities and project status

**Your Profile**
- Bachelor Degree in Electrical, Mechanical or Industrial Engineering or equivalent
- At least 3-5 years of work experience in process / production engineering
- Prior Engineering experience in medical devices industry is preferable
- Experience with manufacturing processes and methods, Lean, Kaizen, Kanban and other advanced manufacturing methodologies, tools and concepts is a must
- 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: 36561 | 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.