Mission
1. Ensure that the requirements from applicable technical standards and technical regulations are correctly interpreted as inputs for development, for test methods and for processes
2. Act as IBA tester for conformity to electromechanical and EMC safety standards and lead negotiations with external laboratories to support accredited testing
3. As a referent expert, take the lead of the interpretation of requirements from standards and technical regulations.
4. Hold a cross-disciplinary look to deal with complex questions regarding the provided technical solutions
Challenges we trust you with
5. Ensure consistency in IBA development projects between requirements from technical standards and regulations and design inputs, test methods and impacted processes.
6. Stay up-to-date on regulatory changes and standards to suggest methodologies, compliance framework and standards
7. Coach and train development Engineers and Physicists on compliance
8. Maintain rules, processes and best practices of IBA internal accredited laboratory.
9. Interface externally with accredited laboratories and key opinion leaders in standardization
What we value
10. A Master degree in (Engineering) Industry, Mechanics or Electromechanics
11. Ideally 4 years or more of hand-on in highly regulated industries are desirable
12. 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).
13. 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).
14. Understanding of regulated quality management systems, good documentation practices, are an asset.
15. Experience in electronic design and simulation is a plus.
16. Good communication skills in English
17. Knowledge of French is an asset
And you also are:
18. Able to research and develop a critical analysis of information
19. Able to produces a range of workable solutions to problems
20. Fascinated by new technologies and always willing to update your knowledge
21. Hands-on, driven and proactive
22. Structured and rigorous and able to organize your work autonomously
23. An assertive team player with good interpersonal skills
24. Ready to travel 10% of your time
Cherry on the cake
25. Experience with medical devices
26. Experience with accredited laboratory
27. Negotiation skills