Senior Design Assurance Engineer

Oxford, United Kingdom          ·             Full time

Job purpose

The Senior Design Assurance Engineer is key member in a team of engineers, based in Oxford, developing a novel neurovascular implant and delivery wire to treat intracranial aneurysms. The Senior Design Assurance Engineer will actively play a vital role in product development activities and provide functional expertise to cross-functional project team members including Project Management, Quality Assurance, Research & Development and Regulatory Affairs.

Duties and responsibilities

• Provide Design Assurance expertise and input to the R&D project team.
• Engage in design control activities according to ISO 13485, FDA 21 CFR Part 820.30 and standard operating procedures (SOPs).
• Participate in the creation of drawing specifications for components, assemblies, finished products, packaging and labelling and identify the critical to quality attributes for products and processes.
• Lead risk management activities according to ISO 14971, including hazard analyses, DFMEAs, PFMEAs, use-related risk assessments and UFMEAs.
• Develop and maintain design verification and design validation plans, protocols, and reports ensure that products meet design inputs and user needs according to their intended use.
• Construct, review and approve scientific rationales/justifications to support verification and validation activities.
• Support internal and external design verification and design validation activities according to verification and validation plans.
• Drive the design, development and validation of test methods to support the R&D projects.
• Create, review and release engineering documentation within the Quality Management System according to SOPs and process engineering change orders.
• Establish and maintain the Design History File and associated documents within the eQMS.
• Collaborate with a cross-functional team to plan, coordinate and conduct human factor validation studies of new products.
• Support Regulatory Affairs and R&D with the preparation of regulatory submissions.
• Develop, review and approve inspection plans and drawing specifications for new products.
• Support design transfer to external contract manufacturers.
• Support the R&D project team to ensure that new design or design changes are adequately evaluated/tested to the requirements of standards.

Qualifications

• Bachelor’s Degree in Mechanical or Biomedical Engineering, Science, QA or related field.
• 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 fast-paced and results-oriented environment.
• Formal training in ISO13485, ISO14971 and FDA QSRs and Human Factors Engineering.
• Strong statistics knowledge and experience.
• Ability to communicate effectively.
• Ability to work independently under minimal supervision from the Project Management Director.

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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