Medical Device Systems Engineer
My Client is a manufacturer of Scientific Instruments used primarily in the Life Sciences sector.
They have a need for a Medical Device Systems Engineer who will support the business in achieving FDA compliance for a medical product based in their R&D Centre in Cambridge.
The Systems Engineer essential duties:
- Review existing design and development documentation and carry out gap analysis against FDA requirements
- Lead the development of Design History File
- Participate in FDA audit preparation meetings and present work to team members
- Experience of delivering FDA compliant medical devices
- Extensive experience in systems engineering
- Experience of developing products to ISO 13485, EN 61010, EMC, IVD, LVD, machinery and environmental regulations
- Multidisciplinary systems development knowledge including software, electronics, mechanical and optics
- Prior experience as a hands-on, project focused engineer
If this role is of Interest to you please apply!
To find out more about Huxley Engineering, please visit www.huxleyengineering.com
Huxley Engineering, a trading division of SThree Partnership LLP is acting as an Employment Business in relation to this vacancy | Registered office | 1st Floor, 75 King William Street, London, EC4N 7BE, United Kingdom | Partnership Number | OC387148 England and Wales