Medical Devices Process Development Engineer (Contract or Permanent)

SJB Technical Recruitment Ltd
Caldicot, UK
15 Sep 2019
28 Sep 2019
Contract Type
Full Time
Medical Devices Process Development Engineer

Cardiff / Bristol area


Our client is an innovative medical device company specialising in the design and development of cutting edge electro-mechanical medical devices and due to exciting growth they now have an immediate requirement for a Process Evaluation / Manufacturing Development Engineer responsible for the qualifying of processes and equipment for the introduction of new product to main stream manufacture.

Experience in medical product process development, process qualification, jig & fixture design and engineering build management would be valuable. This would suit someone who has worked in medical devices as a product evaluation engineer, new product development engineer, quality engineer or a well-rounded project engineer.

Responsibilities include:
  • Design of jigs and fixtures using solid works.
  • Manufacturing of devices containing small parts and low volume manufacturing.
  • Identify process problems and non-conformance's in manufacturing processes and develop corrective actions.
  • Define and perform maintenance and calibration procedures.
  • Drive continuous and process improvements.
  • Project management.
  • Support internal audits and work under ISO13485.
  • Documentation preparation and control.
  • Review procedures for accuracy and make updates using a Document Change Order to reflect process changes, and develop production procedures, standard operating procedures testing and inspection and drawings.
  • Participate in New Product Development teams to establish quality standards for new products and create process procedures, specifications and work instructions as needed and support new product launches.
  • Implement GMP (Good Manufacturing Practices) throughout manufacturing.
  • Coordinate the training of Manufacturing Operators and act as a mentor and technical resource.

  • Experience in using adhesives
  • Laser/ resistance welding skills
  • Advanced Soldering skills
  • PLC control experience
  • Crimping skills
  • Cleanroom experience (ISO class 7/8)
  • Familiarity with ISO13485
  • Solid works experience
  • Familiarity with statistical process control (SPC, CPK's etc.)
  • Experience is designing pneumatical powered tooling
  • Experience of working with external tooling companies
  • Familiar with repeatability & reproducibility

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