OXFORD ENDOVASCULAR  Salary

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9400 GARSINGTON ROAD OXFORD BUSINESS PARK OXFORD OX4 2HN UNITED KINGDOM
TIN: 09769779
 Science & research
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OXFORD ENDOVASCULAR
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OXFORD ENDOVASCULAR is looking for employees for positions:

senior design engineer

  • senior design engineer
  • senior engineer

Working hours

  • full-time

Responsibility

  • 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
  • lead risk management activities according to ISO 14971, including hazard analyses, DFMEAs, PFMEAs, use-related risk assessments and UFMEAs
  • 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
  • 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

Requirements

  • bachelor’s Degree in Mechanical or Biomedical Engineering, Science, QA or related field
  • A minimum of five 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
  • this job is not physically demanding and does not have any special physical requirements
  • ability to communicate effectively
  • ability to work independently under minimal supervision from the Project Management Director