Senior Research Engineer

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The Senior Research Engineer is responsible for solving challenging R&D problems related to polymeric, metallic and ceramic materials, coatings and processing in accordance with the EU Medical Device Regulation. He or she will work in a matrix/cross functional environment and be responsible for acting as a primary liaison in the communication between Research, Development, Quality, Regulatory Affairs and Operations overseeing all relevant standards, updating related processes and specifications and communicating implications to manufacturing internally and externally. Identify and close gaps to meet MDR requirements as related to materials research areasDevelop and implement materials testing and rationales to ensure safe and effective performance of products as well as optimization and implementation of new and revised standardsPerform Standard assessments, delta analyses and assess the impact of changes on current processes and specificationsCreate process descriptions and work instructions in conjunction with test method validation.Write test protocols and technical reports, perform statistical data analysisMonitor and review technical and medical literatureEducate internal colleagues across departments/divisions and provide support for gap closure related to MDR requirements in selected research areas.

Education / Experience Requirements

Minimum qualifications include a Bachelor's degree in Engineering from an accredited curriculum in Materials, Chemical or Biomaterials Engineering, or related discipline; a M.Sc. or PhD. is preferred.2-3 years' R&D experience in medical device industry and related regulatory requirements (MDD/MDR, international standards) This is desirable. If you don't have Medical Device industry expereince but you have a string background in Material Science, you will be considered. Knowledge of metals, ceramic and/or polymer material and coating (e.g. HA, titanium) properties for medical devices, related normative requirements and characterizationKnowledge of material science (particularly physico-chemical, tribological and nanomaterial properties of engineering materials and biomaterials) is preferred.Experience in corrosion and degradation testingExperienced in performing literature studies and statistical data analysisExperienced in writing technical protocols and reportsFamiliar with MDR requirements for permanent implants and surgical instruments (in particular materials related requirements).Familiar with tribology including particles/nanoparticles characterization methods and related international standards

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