Medical Devices Product Support / Service Engineer (Test, Repair, Maintenance)

Oxford

£Neg plus benefits

Our client is a successful Medical Devices start-up company is bringing its first innovative product to market. The product is a complex and challenging instrument, combining electrical and electronic systems, power management, motor controls, sensors and communication systems. It is beyond the prototype stage and the Product Support Engineer will be primarily responsible for

  • The on-site service and repair of complex electro-mechanical medical devices  
  • Working with key service providers managing the global product support network to ensure that product reliability, quality and availability are maintained. 
  • Maintaining all documentation relevant to service, repair and rework in compliance with GMP Documentation and Records.  
  • Providing training to service providers and members of staff
  • Maintaining all service records and work instructions in accordance with quality management system.

RESPONSIBILITIES

  • Organizing and providing on-site service and repair of the device either in person or in collaboration with a service partner:
    • Travelling to hospitals and research facilities worldwide.
    • Ensuring works orders are completed and service visits are well organized.
    • Carrying out on-site or back at base fault finding and re-work of devices and to support other service providers as required.
    • Supporting sub-contract service providers and service activities through training and writing work / supplier instructions.
    • Carrying out acceptance testing and completing all documentation to a high standard.
    • Working with the manufacturing manager to maintain the stock of components and consumables necessary for the support the devices.
  • To contribute to the creation of technical documentation as required under the regulatory frameworks and standards for medical devices
    • Completing test reports and service records.
    • To assist the Technical Director and the Regulatory Affairs Director in risk management as applicable to medical devices under ISO 14971:2007.

SKILLS AND EXPERIENCE

  • Five years or more industry experience servicing and repairing in the medical or other safety critical devices.
  • A good and broad working knowledge of electrical and mechanical engineering systems
  • A good track record of demonstrating analytical problem solving skills
  • Enthusiasm, good communication skills and ability to work effectively in a multi-disciplinary team
  • Ability to work effectively with outside suppliers and manufacturers
  • Ability to work across a wide range of projects simultaneously
  • Ability to produce Technical Reports to a high standard both in terms of technical content, presentation and written English
  • Freedom to travel worldwide to carry out servicing or training as required.

QUALIFICATIONS

  •  A first degree in electrical, electronic, mechanical or biomedical engineering, or other relevant discipline (essential)
  •  A good understanding of complex electro-mechanical systems and software (essential)
  • Excellent knowledge of key office software, including Excel, Word and PowerPoint (essential)
  • Excellent knowledge of engineering software, such as Matlab, Labview and CAD (desirable)
  •  Good hands-on experience with a broad range of test equipment, including oscilloscopes, analyzers and data loggers (essential)
  • Prior experience servicing, repairing and testing medical devices (desirable)
  •  Good working knowledge of the Safety and Quality Standards applicable to medical devices (desirable)

To apply for the role please send your CV and a brief covering letter to simon@sjbtechnical.co.uk