System Architect

Why does this role matter ? 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. He/she supports the establishment of strategic roadmaps, plans, budgets and timelines thereof. 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. The role is vital to ensure that the proposed technical solutions encountered in various situations and the decisions to be taken have an architectural assessment behind and, overall, warrant a robus, reliable and compliant Idylla system. This is NOT a remote position Accountabilities This role includes, but is not limited to, the following responsibilities : The compliance of the Idylla System/Sub-system Design History File (DHF) and related processes with applicable quality regulations (e.g. ISO13485, FDA 21 CFR part 820) and Biocartis standard operating procedures. The technical decisions and selection of technical solutions at System / Platform level in alignment with other relevant stakeholders within Biocartis (e.g. Software Architect, Development Leads, QA/RA OMPS, Product management). Work with stakeholders to define System / Platform needs, and translate them into high-level, consistent requirements, followed by verification and validation thereof. Analyse the different design options, as applicable, to find the best fit, cost and performance. Use system models to understand interdependencies, perform trade-offs, and identify risks early. Find the best technical solutions to solve business needs and System problems; 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. Defend the Idylla System in internal and external audits, as applicable. Bring the strategic view on the next steps for the Idylla System, together with Product Management and other Biocartis stakeholders, in alignment with the vision and mission of Biocartis. Align with the applicable people managers and other technical leads on the allocation of resources to the approved projects, and on the specific budgets and forecasts required. Who are we looking for ? A Master degree or PhD in biomedical engineering, electro-mechanical engineering, mechanical engineering, physics or equivalent by experience/training; At least 12+ year experience excl. PhD (or 8+ incl. PhD) in a relevant position in a product or process development environment. Experience in statistics and data analysis. Experience working in a regulated environment (e.g. ISO13485, FDA 21 CFR 820). 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. What can you expect from us ? 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. A true company culture based on Shared Values. You will have freedom to shape your work and shape your job where you deem it necessary: we value your input. Of course we offer you an appropriate compensation package which includes a Flexible Income Plan.