Medical Devices Process Development Engineer (Contract or Permanent)

Recruiter
SJB Technical Recruitment Ltd
Location
Caldicot, UK
Salary
Competitive
Posted
13 Sep 2019
Closes
29 Sep 2019
Ref
1262127407
Sector
Engineering
Contract Type
Permanent
Hours
Full Time
Medical Devices Process Development Engineer

Cardiff / Bristol area

£Neg

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.

Requirements:
  • 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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