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Systems Engineer

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Location Cambridge, Cambridgeshire Salary
Sector Engineering Type contract

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

To find out more about Progressive Recruitment please visit www.progressiverecruitment.com

Progressive Recruitment, 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