DHF Engineer - contract - medical devices

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DHF Engineer - contractMy client in Cheshire have a long term contract opportunity for an engineer with experience of design remediation in medical devices:Role:Remediation of design and development activities for customer focused sterile and non-sterile medical devices as part of the transition to the MDR.Project activities within a Design Control Framework in accordance with ISO 13485 & 21CFR820 Quality Systems for Medical Devices.Write technical documents to support Design Controls and European regulatory submissions.Contribute to Risk Management activities and other technical assessments.Edit 2D drawings and 3D models & assemblies in accordance with Engineering Change Orders utilising CAD.Develop and Qualify Design Outputs, such as Material Specifications, Sub-Assembly Specifications, Finished Product Specifications, drawings and test methods.Requirements:Relevant degree in Mechanical Engineering or similar.Excellent problem solving skills.Experience of injection molded parts, electro-mechanical enclosures & assemblies, bonding techniques and fabrics.An understanding of Design Control, Risk Management and Process Validation.Experience of developing and applying statistical sampling plans during development projects is desirable.An understanding of Medical Device Regulations such as MDD, CFR or MDRExperience working within the Pharmaceutical or Medical Devices Industries or an equivalent regulated industry. To find out more about Real please visit www.realstaffing.comReal Staffing, 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