Job Description
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 crossfunctional project team members including Project Management, Design Assurance, Quality Assurance and Regulatory Affairs.
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.
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 fastpaced 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.
Working conditions
This job does not require the person to work in special working conditions.
Physical requirements
This job is not physically demanding and does not have any special physical requirements.
