|Job Ref:||204438815||Employer:||cv-library.co.uk||Industry:||Civil and Structural||Job Type:||Permanent||Country:||United Kingdom||City:||Newport||Address:||Post Code:||GL13||Salary:||£50000 - £60000/annum plus benefits||Post Date:||24/10/2016 10:50|
Medical Devices Senior Project Manager (ISO13485 Product, Regulatory)|
Cardiff / Bristol area
£50k - £60k + benefits
Our client is an innovative medical device company specialising in the design and development of cutting edge electro-mechanical medical devices. They now have an immediate requirement for a Senior Project Engineer/Technical Project Manager to drive forward new product development through the necessary medical regulatory requirements into and into production as the company enters a very exciting stage in its development.
Formal product development from concept completion to production and beyond.
Input to design and development activities to ensure that project targets and timescales are met, knowledge of Solidworks or similar would be beneficial.
Conduct design / product / process verification and validation requirements according to Medical Device regulations ISO 13485 and IEC 60601
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.
Demonstrate a proactive role in anticipating potential issues to ensure progress is uninterrupted.
Use a hands-on or analytical approach to provide technical guidance and resolution of any outstanding problems.
Be mindful of risk reduction strategies and lead risk analysis and FMEA's.
IDEAL CANDIDATE PROFILE
A good degree qualification combined with a high level of technical competency (both analytical and practical), preferably a first degree in Medical or Mechanical Engineering.
Minimum of five years plus postgraduate industrial experience in the design and development of medical devices
A logical approach to the solution of problems and to the product development process with the capacity for original thinking.
The ability to work alone and unsupervised or as part of a closely integrated project team and give guidance to other project engineers
An enthusiastic and a well organised approach with excellent communication and PC skills (MS Office)