The Senior R&D Engineer is a key member of an engineering team based in Oxford, developing a novel neurovascular implant and delivery wire to treat intracranial aneurysms. The Senior R&D Engineer will actively play a vital role in product development activities and provide technical expertise to crossfunctional project team members including Project Management, Quality Assurance and Regulatory Affairs.
Duties and responsibilities
- Develop and test prototypes to demonstrate technical feasibility of new design concepts.
- Engage 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, finish product, packaging and labelling and identify the essential outputs for the proper functioning of the device.
- Participate in risk management activities according to ISO 14971, including hazard analyses, DFMEAs, PFMEAs, use-related risk assessments and UFMEAs.
- Develop verification and validation plans, protocols, and reports as a part of design verification and design validation to ensure that products meet design inputs and user needs according to its intended use.
- Construct robust scientific rationales/justifications to support verification and validation activities.
- Manage internal and external design verification and design validation activities according to verification and validation plans.
- Create, review and release engineering documentation within the Quality Management System according to SOPs and process engineering change orders.
- Engage with clinicians to define user needs and obtain feedback on prototypes.
- Work closely with contract manufacturers to produce prototypes, optimize designs for manufacture and support the transfer of designs to manufacturing.
- Support Regulatory Affairs with the preparation of regulatory submissions
- Bachelor’s Degree in Mechanical Engineering or Biomedical Engineering.
- A minimum of five (5) 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.
- Strong design expertise using SolidWorks including ability to generate complex designs, detailed 2D drawings and BOMs.
- Ability to communicate effectively.
- Ability to work independently under minimal supervision from Director of Development
This job does not require the person to work in special working conditions.
This job is not physically demanding and does not have any special physical requirements.