Manufacturing Engineer (PR-34099864)

Manufacturing Engineer for Medical Devices Industry

This role will be primarily responsible for implementing Life Cycle Management changes & New Product Introduction (limited), escalation management and process improvements.

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 team leads, 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 and execute New Product Introductions.
• Support & execute Process Validation
• Providing input for the Manufacturing Engineer, to create a better way of working. After release for volume production the Sustaining 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.

Requirements

• Typical bachelor in industrial engineering or mechatronics or comparable. Master level is over qualification.
• Hands-on mentality, proficient in documentation and natural inclination for accuracy.
• Be independent, pro-active, and not afraid to take ownership, including relevant stakeholder's management.
• Experience in statistics and process validation or eager to learn this knowledge.
• A result & quality driven approach.
• Experience within Manufacturing or Engineering within high tech industry.
• Experience with OT (Operational Technology) and IT (Information Technology).
• Comprehension skills and ability to analyze and summarize.
• Technical knowledge to identify tooling issues and translate R&D requirements towards a manufacturing process, in collaboration with R&D and tooling suppliers.
• Experience with quality management and quality systems. Preferably experience in the medical industry (ISO 9001, 13485, FDA requirements, audits, FMEA, 8D, SPC etc.
• Dutch and English