R&D Engineer for a novel neurovascular implant

1. Job purpose Candidates should take the time to read all the elements of this job advert carefully Please make your application promptly. The R&D Engineer II is a key member of an engineering team based in Oxford, developing a novel neurovascular implant and delivery wire to treat intracranial aneurysms. The R&D Engineer II will actively play a vital role in product development activities and provide technical support to cross-functional project team members including Project Management, Design Assurance, Quality Assurance and Regulatory Affairs. 2. Duties and responsibilities • Support the design, build and testing of prototypes to demonstrate the technical feasibility of new design concepts. • Participate in design control activities according to ISO 13485, FDA 21 CFR Part 820.30 and standard operating procedures (SOPs). • Create and maintain drawing specifications for components, assemblies, finished product, packaging and labelling. • Participate in risk management activities according to ISO 14971, including hazard analyses, DFMEAs, PFMEAs, use-related risk assessments and UFMEAs. • Develop test plans, protocols, and reports as a part of design verification and validation to ensure that products meet design inputs and user needs. • Manage internal and external design verification and design validation activities according to verification and validation plans. • Design and 3D print internal test fixtures and tooling. • Maintain written records of materials, processes and inspection methodologies used during prototype production. • Identify product quality defects and manufacturing challenges during prototype production to inform the development of design specifications and process improvement activities. • Organise and maintain lab equipment and manage stock levels for materials and components. • Create engineering documentation within the Quality Management System according to SOPs and process engineering change orders. • Support the engineering team with the preparation of technical documentation. • Effectively communicate concepts, ideas, progress and results to team members. 3. Qualifications • Bachelor’s Degree in Mechanical Engineering or Biomedical Engineering. • A minimum of 2 (two) years of experience in class II or class III medical device product development, preferably intravascular devices. • Demonstrable analytical and problem-solving skills, and ability to handle multiple tasks in a fast- paced and results-oriented environment. • Ability to generate 3D CAD models and drawings using SolidWorks. • Ability to communicate effectively. • Ability to work independently under supervision from Senior R&D Engineers and the Director of Development.