Publication date
Department
R&D - Engineering (software, system, mechanical)
Country
Belgium
Location
Mechelen
Work arrangement
Hybrid
Travel percentage
0%
Function type
Full-time
Contract type
Employee
Experience required

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).

Education

Master's degree in bio-engineering, mechanical engineering, electro-mechanical engineering, physics or equivalent by experience and/or experience; 

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

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.

Apply now

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