Requisition ID: 3685
Location:
Louvain-la-Neuve, BE
Work regime: Full-Time
Kind of contract: Open Ended Contract
Mission
- Ensure that the requirements from applicable technical standards and technical regulations are correctly interpreted as inputs for development, for test methods and for processes
- Act as IBA tester for conformity to electromechanical and EMC safety standards and lead negotiations with external laboratories to support accredited testing
- As a referent expert, take the lead of the interpretation of requirements from standards and technical regulations.
- Hold a cross-disciplinary look to deal with complex questions regarding the provided technical solutions
Challenges we trust you with
- Ensure consistency in IBA development projects between requirements from technical standards and regulations and design inputs, test methods and impacted processes.
- Stay up-to-date on regulatory changes and standards to suggest methodologies, compliance framework and standards
- Coach and train development Engineers and Physicists on compliance
- Maintain rules, processes and best practices of IBA internal accredited laboratory.
- Interface externally with accredited laboratories and key opinion leaders in standardization
What we value
- A Master degree in (Engineering) Industry, Mechanics or Electromechanics
- Ideally 4 years or more of hand-on in highly regulated industries are desirable
- Knowledge of electrical safety based on IEC/EN 60601-1 (Medical Electrical Equipment) or on equivalent is an asset (for example IEC/EN 60204-1 -Safety of machinery, IEC/EN 61010-1 electrical equipment for measurement, control, and laboratory use).
- Knowledge of Electromagnetic compatibility (EMC) based on IEC/EN 60601-1-2 ("Medical Electrical Equipment-Electromagnetic disturbances"), or on equivalent is an asset (for example IEC/EN 61000-4-x family, IEC/EN 61326-1 product family).
- Understanding of regulated quality management systems, good documentation practices, are an asset.
- Experience in electronic design and simulation is a plus.
- Good communication skills in English
- Knowledge of French is an asset
And you also are:
- Able to research and develop a critical analysis of information
- Able to produces a range of workable solutions to problems
- Fascinated by new technologies and always willing to update your knowledge
- Hands-on, driven and proactive
- Structured and rigorous and able to organize your work autonomously
- An assertive team player with good interpersonal skills
- Ready to travel 10% of your time
Cherry on the cake
- Experience with medical devices
- Experience with accredited laboratory
- Negotiation skills