Senior System Engineer

Senior System Engineer

Biocartis

Mechelen, Belgium

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:

• 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 engineering
• Lean 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 asset