The System Architect is a technical leader with overview on all OMPS Platform activities with a strong focus on the hardware side of the Idylla Platform. Moreover, he/she provides a holistic view of the Idyll System, ensuring all parts fit together and all relevant stakeholders (such as Software Architect, Development Leads, QA/RA OMPS, Product Management) are aligned, wile identifying risks early. This is NOT a remote position !
The compliance of the Idylla System/Sub-system Design History File (DHF) and related processes with applicable quality regulations (e.g. Software Architect, Development Leads, QA/RA OMPS, Product management).
Analyse the different design options, as applicable, to find the best fit, cost and performance.
propose and defend improvement projects, supporting the creation of solid business cases.
Maintain a full overview of OMPS Platform Hardware quality events, projects, improvements (proposals) and guide the team in the technical work thereof, as applicable.
Document, present, explain and train people on existing and proposed system solutions and their architecture; serve as bringing a common language between engineers, (senior) managers, and other stakeholders.
A Master degree or PhD in biomedical engineering, electro-mechanical engineering, mechanical engineering, physics or equivalent by experience/training;
PhD (or 8+ incl. PhD) in a relevant position in a product or process development environment.
Experience in statistics and data analysis.
NB: experience in a non-medical regulated environment will be considered as well (e.g. aerospace, automotive, defense).
Language skills : English: professional working proficiency both written and spoken. Dutch is an asset.
We offer you an exciting job in a fast growing international and innovative environment where you can work with top entrepreneurs in the biotech industry. You can be part of a very dynamic, young and growing team.
You will have freedom to shape your work and shape your job where you deem it necessary: we value your input.