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.
- 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.
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.