Systems Engineer

This job has now expired please search on the home page to find live IT Jobs.

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 requirementsProduce all necessary FDA compliant documents including, but not limited to, Requirements Specification, Design Specification, Hazard analysis, Traceability analysis, Verification and Validation, Risk assessmentLead the development of Design History FileGather necessary information from internal and external sourcesParticipate 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 experienceExperience of delivering FDA compliant medical devicesExtensive experience in systems engineeringExperience of developing products to ISO 13485, EN 61010, EMC, IVD, LVD, machinery and environmental regulationsMultidisciplinary systems development knowledge including software, electronics, mechanical and opticsPrior experience as a hands-on, project focused engineerAbility to understand complex project work within a short space of timeAbility to adapt to new systems and processes within a short space of time To find out more about Progressive Recruitment please visit www.progressiverecruitment.comProgressive 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