Mechanical Engineer - Medical Devices
Do you want to play a key role within Manufacturing in IGT (Image Guided Therapy) and MR (Magnetic Resonance)? As Manufacturing Engineer, you are the representative of Operations in multi-disciplinary teams ensuring best in class transition from development to manufacturing. Besides this you have the opportunity to make IGT and the MR factory as Lean as possible (productivity is key).You have an important role within process improvements, Quality, execution and control of all validation activities related to Life Cycle Management (LCM) changes, including process, equipment, tool, SW validation, and statistical analysis. Have you always had an interest in understanding the processes within the factories? Are you driven to find efficiency opportunities within the current processes? Do you have technical knowledge, like to be creative and not afraid to go against the status quo, then this role might be the right next step for you!
You are responsible for
Writing work instructions, monitor/maintain devices and tooling, instruct employees, implement and maintain production processes. Maintaining Tooling within your building block. Introducing new production-methods (technical & logistic), within own Building block. DEFOA/MOA Root cause analysis, creating and implementing structural solutions. Minimum disturbances (max. Yield) within production in cooperation with team leads, troubleshooters and development. Executing peer reviews and authorizing validation documentation as indicated by the procedures. Participating in supply chain teams, design teams, purchasing teams and secures the agreed manufacturing requirements. Defines, implementing new/changed processes and leading the first production models for projects. Defines and leads improvement projects for the assigned unit, to improve efficiency, product quality and test section. Performing technical analysis and conducting or participating in feasibility studies of improvements (business cases).Provides input for Manufacturing requirements in PDLM. Creating Quality Control Plan. Providing structural solutions by initiating amendments like problem reports (PR) and/or 8D forms. Giving support, improve and maintain the production process within the Engineering Department. Escalating, assessing of changes and maintenance of processes. Analysis of performance data with respect to products and processes (Six-sigma, SPC)Participating as an expert in audits. Taking ownership of implementing significant improvements based on the road mapping. Investigation and escalation of Production issues/complaints, if needed together with development. Executing theCorrective/Preventive. Action process, for process and product quality in the factory.Executes Capex optimization for repeat investments.
You are part of
The Manufacturing Engineering team IGT/MR, which in return is part of the larger Engineering team at Factory Best, who are responsible for processes withinIGT/MR/SP&R/IC/RS. To succeed in this role, you should have the following skills and experience. Experience within Manufacturing or Engineering with high tech medical devices. Experience with FMEA, 8D, SPC, A3, Lean Manufacturing. Experience with OT (Operational Technology) and IT (Information Technology)Be independent, pro-active, and not afraid to take ownership, including relevant stakeholders and communicating progress. Ability to understand complex situations and able to quickly understand new environments, enabling flexibility to work in various Factory Best building blocks or modalities simultaneously. Positive attitude and energy to drive change. A result driven and quality driven approach. Technical insight and natural inclination for accuracy. Preferably Green Belt or Lean certified. Minimum technical bachelors degree. Fluent in Dutch and English.