Beschreibung
Essential:
• Someone that knows the standard of the device (IEC 60601)
• From an engineering background
• Hands-on testing experience
• Experience of writing testing protocols & test method validation
• A very hands-on position – the candidate needs to be prepared for that
• Need to be able to read a gap analysis – MDD to MDR and then understand what is needed to understand the gap and fill the gap
• Electromagnetic compatibility experience
• Come from a Medical Device Background
Desirable:
• Process validation and understanding the equipment is important
• Design and risk management – having worked with design risk analysis and understanding risk management could be helpful
• Packaging validation should be quite straight forward and goes to external test labs – There is not the need to have to create a new test method it’s only needed to manage the communication with external labs for packaging validation
• Experience of performing testing in a emc lab
• MDR experience
The Contract:
• 12 Month Contract
In order of priority of the positions is as follows:
1. Test Engineering should have knowledge on basic safety and essential performance concepts from IEC
2. hands-on skills on , expert in electromagnetic compatibility, experience in performing the test in a emc lab.
3. expert in writing Test reports according to medical standard requirements
4. be able to resolve identified gaps (including testing if needed) with the support of R&D/Operations, or write justification to fill the gap. – execute and solve the gap – that’s why I think
5. expert in Design FMEA and Risk Management, Definition of Critical components and lifetime of a medical device according to Risk Management files
6. Performing packaging and transportation tests with external labs according to relevant standards
7. Understanding the basic requirements, for MDR especially ANNEX I