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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.
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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.
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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.