Description
You will be responsible for delivering the necessary documents required for a FDA pre-market submission of a medical product.
Reporting to the Engineering Manager the role holder will deliver necessary documents required for FDA - 510(K) Pre-market submission for a Biochrom medical product.
You will need the following experience to apply:
- Review existing design and development documentation and carry out gap analysis against FDA requirements
- Produce all necessary FDA compliant documents including, but not limited to, Requirements Specification, Design Specification, Hazard analysis, Traceability analysis, Verification and Validation, Risk assessment
- Lead the development of Design History File
- Gather necessary information from internal and external sources
- Participate in FDA audit preparation meetings and present work to team members
- Degree in a relevant engineering discipline with a minimum of 10 years relevant industry experience
- 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
- Ability to understand complex project work within a short space of time
- Ability to adapt to new systems and processes within a short space of time
Progressive Recruitment, a trading division of SThree Partnership LLP is acting as an Employment Business in relation to this vacancy | Registered office | London, EC4N 7BE, United Kingdom | Partnership Number | OC387148 England and Wales