Process Engineer x 4 – Contract – Medical Devices
Duration: Initially 6 months (Very likely to extend further)
Rate: £(Apply online only) per day (based on an 8 hour day)
Our rapidly expanding, dynamic, and innovative MedTech client is on the look out for 4 x Contract Process Engineers to join they’re cutting edge Team.
***Medical Devices / Medical Device Industry experience is ESSENTIAL!!
These Contracts are urgent and we’re ideally looking for Process Engineers / Manufacturing Process Engineers who can either start immediately or within 4 weeks, latest!
• 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 Manufacturing 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 procedure to reflect process changes, and develop production procedures, standard operating procedures testing and inspection and drawings.
• Define and perform maintenance and calibration procedures.
• Drive continuous and process improvements.
• Project management.
Key skills, behaviours, competency and experience you’ll need:
• First class engineering standards.
• Excellent engineering and root cause analysis problems solving skills (demonstrable use of the full range of problem-solving tools) with an ability to trouble shoot mechanical, electrical and electronics designs, carry out failure mode analysis and support mechanical design changes.
• Excellent product and process validation and verification expertise including IQ/OQ/PQ DOE and TMQs.
• Statistical analysis (preferably experienced with use of Minitab).
• Thorough understanding of 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.
• Experience of designing products and performing verification to meet IEC60601 test standards, specifically -1, -1-2, -2-18.
• 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.
Please reach out ASAP if you’d like to hear more about these Contract Process Engineer opportunities.
Salary: £280 – £340/day
Job Type: Contract
Location: Monmouth, Monmouthshire
To apply for this job please visit www.cv-library.co.uk.