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 areas
- Develop and implement materials testing and rationales to ensure safe and effective performance of products as well as optimization and implementation of new and revised standards
- Perform Standard assessments, delta analyses and assess the impact of changes on current processes and specifications
- Create process descriptions and work instructions in conjunction with test method validation.
- Write test protocols and technical reports, perform statistical data analysis
- Monitor and review technical and medical literature
- Educate 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 characterization
- Knowledge of material science (particularly physico-chemical, tribological and nanomaterial properties of engineering materials and biomaterials) is preferred.
- Experience in corrosion and degradation testing
- Experienced in performing literature studies and statistical data analysis
- Experienced in writing technical protocols and reports
- Familiar 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.com
Real 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