Why does this role matter ?The Senior Hardware System Engineer is a technical expert supporting development, optimization and maintenance of the system, especially those aspects related to sub-systems integration and interactions (instrument, console, cartridges and various assays).
Make sure to apply with all the requested information, as laid out in the job overview below.
The Senior System Engineer will lead problem-solving activities in multidisciplinary and cross-functional teams.He or she:conducts strategic planning for the development of the Idylla system, its sub-systems and related processes in line with cross-functional business requirements;defines scope and problem domain with all stakeholders;defines, documents and communicates development scenarios and trade-off analyses supporting the decision process;supports the establishment of strategic roadmaps, plans, budgets and timelines;explains solutions and decisions, convinces implementation teams and stakeholders;leads implementations;is a mentor and coach for other technical roles;provides training in own expertise domains;drives continuous improvement of the System Engineering competence;Who are we looking for ?Master's degree in bio-engineering, mechanical engineering, electro-mechanical engineering, physics or equivalent by experience and/or experience;At least 5+ year experience 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, defence).Practical experience with design and development of at least one of the following types of products:Plastic consumables;Mechatronic products (HW and SW).Professional experience in the following disciplines is considered an asset:System engineering;Plastic moulding and/or welding;Mechanics/physics of fluids;Process engineeringLean Six Sigma;Test automation;Reliability engineering.Familiar with data analysis and statistical analysis tools (e.g.
Spotfire, R, Python, Minitab, MATLAB);Knowledge of quality and compliance standards for development of medical devices / IVD systems (ISO13485, ISO14971, FDA 21 CFR part 820) is an asset;Language skills : English: professional working proficiency, both spoken and written, is required.
Dutch is an assetWhat 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.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. xjsrcvq
We offer a lot of flexibility and attention to your wellbeing via a hybrid work regime.