One of our leading medical device clients has an opening for a Sustaining Engineer in Eindhoven. We are looking for someone with a technical background in engineering, documentation and manufacturing processes preferably in the medical device industry.
As a Sustaining Engineer you are responsible for giving support, improving, and maintaining the production process within the Sustaining Engineering Department. You are responsible for writing and maintaining work instructions for manufacturing processes. You are also involved in continuous improvement projects and specifying requirements from Operations.
As a Sustaining Engineer you are responsible for giving support, improve and maintain the production process within the Sustaining Engineering Department Factory Best. You are responsible for writing and maintaining work instructions for manufacturing processes.
- 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
- Minimum disturbances (max. yield) within production in cooperation with team leads, trouble-shooters and development. Preparation and introduction of product changes through Life Cycle Management/Business and New Product Introductions within production / systems.
- Participates as an expert in audits.
- Give support and set up New Product Introductions.
- Support 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, SPC)
- 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.
- Hands-on mentality
- knowledge to identify mechanical and electrical tooling issues
- Skills in escalation management
- General engineering knowledge
- Affinity with documentation (e.g., work instructions, escalation documentation and process validation.
- Personal & communication skills (Dutch & English).
- Supporting NPI
Desired skills and experience:
- Typical bachelor in mechatronics, industrial engineering or comparable,
- 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.
- Leader skills
PROJECT START DATE
If you are interested in the above description, please apply with your CV and a letter of motivation by clicking on the ‘apply’ button below.
PS: Did you also know that we offer a generous referral scheme, because great people know other great people, right?
For further information, please contact Ralph Looijen at +31 (0)20 20 44 502 or by email at firstname.lastname@example.org