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Contract Medical Devices Process Development Engineer

SJB Technical Ltd
Job LocationRogerstone
EducationNot Mentioned
Salary£350.00 - £400.00 per day
IndustryNot Mentioned
Functional AreaNot Mentioned
Job TypeContract, full-time

Job Description

Contract Medical Devices Process Development EngineerCardiff / Bristol area£350 - £400 p/day or permanentOur 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 Permanent or Contract 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 is essential. 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.KEY TASKS

  • Development of manufacturing and verification jigs and fixtures, poke yoke design etc.
  • Manufacturing of devices containing small parts and low volume manufacturing.
  • Perform qualifications including IQ/OQ/PQ of jigs and fixtures.
  • Ensure the impact of design and process changes are fully assessed and necessary revisions to the technical file are made using engineering change control procedures.
  • Manage and execute V&V activities associated with design or process changes.
  • Test method qualification, Protocol generation, Report writing.
  • Identify process problems and non-conformance’s in manufacturing processes and develop corrective actions.
  • Implement GMP (Good Manufacturing Practices) throughout manufacturing.
  • Coordinate the training of Operators and act as a mentor and technical resource.
  • Support internal audits and work under ISO13485.
  • Review procedures for accuracy and make updates using a Document Change Order
  • Define and perform maintenance and calibration procedures.
  • Drive continuous and process improvements.
  • Project management.
    • Key skills
  • Excellent engineering and root cause analysis problems solving skills with an ability to trouble shoot mechanical, electrical and electronics designs
  • Excellent product and process validation and verification expertise including IQ/OQ/PQ DOE and TMQs.
  • Statistical analysis (preferably experienced with use of Minitab).
  • MVP, PFMEA, Manufacturing plan, manufacturing process flow.
  • Degree qualified or equivalent skills from a mechanical, electronic, manufacturing, product engineering-based discipline.
  • Excellent abilities with CAD, specifically Solidworks.
  • Designing products and performing verification to meet IEC60601 test standards,
  • Highly experienced working within a Quality Management System ISO13485.
  • An ability to multi-task and work under pressure to meet tight deadlines.
  • Experience in using adhesives
  • Laser and resistance welding skills
  • Induction solder experience
  • Advanced soldering skills
  • PLC control experience
  • Crimping and mechanical joint experience
  • Cleanroom experience (ISO class 7/8)
  • Experience of working with external tooling companies
  • Experience with DFM
  • Ability to work under pressure.
  • Can do attitude.

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