System Engineering Lead
Posted on Oct 15, 2020 by Consol Partners
System Engineering Lead (Consultant)
6 months contract (extendable)
Our client are developing a radically innovative testing solution for airborne infectious diseases. When this technology is rolled out, it will cause a paradigm shift in how we monitor and control pandemics. Success for this project depends on a multidisciplinary approach within a team that has expertise in electronics, assay development, optics, software, IVD development and a drive to get things done under strict design control and timelines. We aim at research and development at the highest international level and are building an all-star team to get it done.
We are looking for an (experienced) System Engineering Lead with a strong background in the development of complex medical or lab devices, following strict design control. This position reports to the IVD program manager.
You will take the lead in collecting all the requirements from user interactions, market analyses and regulatory advice, and building a complete user requirements document. Together with the technical experts you will build a system architecture and translate this into the technical design specifications for the whole system. Throughout the development, you will organize design review moments and risk analysis sessions, follow up on technical progress, while updating and maintaining the requirements, using professional software tools. You will become the liaison between the different development teams, able to provide the eagle eye perspective in technical discussions.
- Lead the collection and structuring of the user requirements, via professional software
- Interact with the different stakeholders: end-users, customers, regulatory bodies
- Interact with the technical experts to translate the user requirements into system requirements
- Become the representative of the system as a whole, the liaison between the specialists
- Track the requirements throughout the product development, via design reviews
- Track the risks and mitigations via different risk analysis methods
- Track the progress of the verification and validation activities
Required knowledge and skills
- You have a technical background in engineering, physics, biochemistry or similar
- You have experience in development of complex (medical) instruments
- Experience in IVD development is a strong plus
- Experience with requirement tracking software is a plus
- A team player with excellent communication skills and fluent in English