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- You will take part in the process of defining product development requirements and you will provide support to the project managers during the design phase.
- You will ensure that the interactions between the various sub-systems (biological products, instruments, data manager) are clearly defined.
- You will establish a requirement management process and ensure a formal link between the marketing and development teams.
- You will define and organize the documentation structure in line with IVD regulatory requirements.
- You will establish a matrix linking needs, specifications and integration, Verification and Validation testing.
- You organize and lead the design reviews
- You will contribute to establish integration, verification and validation plans.
- You will participate on the DHF (Design History File) definition and its achievement
- You will contribute to innovation and technology survey
- You hold a degree in biology/biomedical or an equivalent qualification.
- You have already a first professional experience in systems architecture and you are familiar with the product development process
- You have some knowledge in diagnostic instrumentation
- Project management skills are an asset.
- You like to work in an international environment and are prepared to travel within Europe occasionally.
- You are fluent in English and have good skills in French
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