We’re Hiring: Senior R&D Engineer role

Oxford, United Kingdom          ·             Full time

Job purpose

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

Qualifications

• 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

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.

Please enquire by sending your CV and a cover letter to Rob Eyers at:

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