Favourite

Design and Development Engineer

  • Reference IP31163-RA
  • Location Bristol
  • Job type Contract

A highly innovative medical device manufacturer in the Bristol area currently require a contract Design & Development Engineer to join their team on an initial 6-month contract. This company are genuinely revolutionising certain surgical procedures and the successful candidate/contractor will be working on high tech, innovative products which will have a huge impact on people’s lives.

The role will consist of the design and development of class IIb medical devices with the primary focus of supporting an update programme to an existing surgical instrument. The project requires final completion of updates to design and development and verification and validation of the product changes.

They are open to both an hourly/daily rate contract or a 6-month fixed term position. On offer is a highly competitive rate. The successful candidate/contractor should have extensive experience working on electrosurgical and/or class IIb medical device design & development.


Key tasks for position holder:

Continued development and implementation of the design update to a class IIb device
Ensure design changes and the impact are fully assessed and necessary revisions to the technical file are made
Development of manufacturing and verification jigs and fixtures
Manage and execute V&V activities associated with the design change
Test method qualification
Protocol generation
Preparation of technical documents such as risk analysis, FMEA, component specifications, technical reports including verification and validation reports etc. for incorporation into the technical file

Experience/skills

Electrosurgical and/or class IIb medical device design and development expertise; having developed a device from concept through to regulatory release
Proficient with SolidWorks
Experience of designing products and performing verification to meet IEC 60601 test standards
Excellent engineering and root cause analysis problems solving skills
Degree qualified in a relevant engineering discipline (or equivalent experience)
Highly experienced working within ISO1 34385

Sign up for industry updates