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
Qualifications
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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