| YOU ARE RESPONSIBLE FOR

• Writing work instructions, monitor/maintain devices and tooling, instruct employees, implement and maintain production processes.
• Defect On Arrival (DEFOA) /Missing On Arrival (MOA) Root cause analysis, creating and implementing structural solutions.
• Providing structural solutions by initiating amendments like problem reports (PR) and/or 8D forms (Problem Solving methodology)
• Minimum disturbances (max.Yield) within production in cooperation with teamleads, troubleshooters and development.
• Preparation and introduction of product changes through Life Cycle Management and New Product Introductions within the manufacturing process
• Participates as an expert in audits
• Give support to New Product Introductions.
• Support & execute Process Validation
• Providing input for development, to create a better way of working. After release for volume production the Manufacturing Engineer is accountable for improvements.
• Analysis of performance data with respect to products and processes (Six-sigma, Statistical Process Control)
• Give input and maintain the New Product Introductions project planning.
• Perform preparation activities on trial/prototype production within New Product Introduction-processes
• Defines and leads improvement projects for the assigned unit, to improve efficiency, product quality and test section (Green Belt).
• Investigation and escalation of Production issues/complaints, if needed together with development.

You are part of Factory Best, one of the largest Operations sites in Health Systems. Your part of Manufacturing Engineering, a team which is responsible for processes within:

• Imaging Guide Therapy (IGT)
• Magnetic resonance imaging (MR))

You will be working closely with the manufacturing and development department. To succeed in this role, you should have the following skills and experience:

• Typical bachelor in mechatronics, industrial engineering or comparable, with IT knowledge.
• Hands-on mentality
• Technical knowledge to identify mechanical and electrical tooling issues and solve them in collaboration with R&D and maintenance department/manufacturer
• Experience with project management, quality management and quality systems. Preferably experience in the medical industry (ISO 9001, 13485, FDA requirements, audit planning and execution, FMEA, 8D, etc.).
• Experience within Manufacturing or Engineering with high tech medical devices.
• Preferably Green Belt or Lean certified.
• Comprehension skills and ability to analyze and summarize.
• A result driven and quality driven approach.
• Personal & communication skills (Dutch & English).

Below are practical examples from the Job:

• Establish new production layout.
• Support equipment installation of ordered equipment.
• Execute process & equipment validation.
• Support of the first production run.
• Resolve unclear process description in the work instruction.
• Resolve unknown error messages in production (escalation management).
• Optimize production flow in order to increase production output.
• Introducing Statistical Process Control in order to improve First Past Yield.

Following elements are the main activities of the job:

• Establish new production layout
• Support equipment installation of ordered equipment
• Execute process & equipment validation
• Lead production escalations
• Improve production process

| WHAT DO WE EXPECT FROM YOU?

• IT knowledge is required (understand equipment architecture, industrial 4.0 step up (preferable electro/mechanic profile).
• Hands-on mentality.
• Technical knowledge to identify mechanical and electrical tooling/product issues.
• General Engineering knowledge.
• Affinity with documentation, e.g. work instructions, escalation documentation and process validation.
• Support New Product Introductions.