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We are looking for an Engineer to work within the existing engineering teams of a Cambridge based company to provide independent verification and validation of their products during new product introduction and manufacturing. This is a hands-on role requiring a statistical approach to problem solving.
* Plan verification and validation programmes, including interpretation and implementation of relevant standards, and establishment of acceptance criteria for assessing the performance of new products during product development and manufacture
* Design, develop and conduct verification and validation tests to demonstrate the performance of products at a system level.
* Perform analysis and interpretation of test data, including statistical analysis where necessary.
* Review requirements for traceability and testability.
* Lead product design risk management activities using appropriate techniques (such as DFMEA, Fault Tree Analysis)
* Assist the project teams to solve design and development problems using root cause analysis and statistical techniques
* Supporting creation of Technical Files / Design History Files
* Contribute to the overall compliance of the Products, and identification of gaps (including documentation) to regulatory and the Quality System requirements.
* Take an active role in Design Reviews to assess quality and compliance.
* A degree in Engineering or related technical discipline with 3+ years' experience of working in a product development environment covering the following areas:
* Conducting Device Risk Management, Design Verification and Validation activities
* Defining system test approaches incorporating software, electronics and mechanics
* Familiarity with working within ISO9001 Quality Systems
* Excellent communication skills and the ability to constructively critique the work of others to obtain the best product possible.
The following would be advantageous:
* Experience of working with a regulatory environment (such as medical device product development to ISO13485)
* Knowledge of statistical techniques (such as 6-Sigma)
[ Cambridge, Salary £neg. | vacancy reference : 31620 ]