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Manufacturing Process Development Engineer (Graduate, Medical Devices)

SJB Technical Ltd
Job LocationBradley Stoke
EducationNot Mentioned
Salary£30,000 - £40,000 per annum
IndustryNot Mentioned
Functional AreaNot Mentioned
Job TypePermanent, full-time

Job Description

Manufacturing Process Development Engineer (Graduate, Medical Devices)Cardiff / Bristol area£30k - £40kOur 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.This role could potentially suit a recent graduate with 1-3 years’ hands-on experience of designing and manufacturing small scale electro-mechanical products in a highly regulated environment such as aero, auto, defence etc and a keen interest to move into or progress in the medical devices sector.An interest in building experience in medical product process development, process qualification, jig & fixture design and engineering build management is essential.Other suitable previous / current roles would be 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.
    • Key skills
  • Degree qualified or equivalent skills from a mechanical, electronic, manufacturing, product engineering-based discipline.
  • Engineering and root cause analysis problems solving skills with an ability to trouble shoot mechanical, electrical and electronics designs
  • Product and process validation and verification expertise
  • Statistical analysis (preferably experienced with use of Minitab).
  • MVP, PFMEA, Manufacturing plan, manufacturing process flow.
  • Solidworks CAD or similar
  • Designing products and performing verification to meet Electrical test standards,
  • Highly experienced working within a Quality Management System
  • Joining techniques using adhesives, Laser and resistance welding, Induction solder experience, advanced soldering skills, crimping and mechanical joint
  • PLC control experience
  • Cleanroom experience (ISO class 7/8)
  • Experience of working with external tooling companies
  • Experience with DFM
  • An ability to multi-task and work under pressure to meet tight deadlines.
  • Ability to work under pressure.
  • Can do attitude.

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