- 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;
- Plastic consumables;
- Mechatronic products (HW and SW).
- System engineering;
- Plastic moulding and/or welding;
- Mechanics/physics of fluids;
- Process engineering
- Lean Six Sigma;
- Test automation;
- Reliability engineering.
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Senior System Engineer - Mechelen - Biocartis
Beschrijving
Why does this role matter ?
The Senior 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). The Senior System Engineer will lead problem-solving activities in multidisciplinary and cross-functional teams.
He or she:
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:
Professional experience in the following disciplines is considered an asset:
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 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.
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. We offer a lot of flexibility and attention to your wellbeing via a hybrid work regime.
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