1.    Job purpose

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.