Senior Consultant Electrical Safety (IEC 60601-1 and Design Controls)
Netherlands, Gelderland, ArnhemMedical Devices
What you'll do
Currently, Qserve has an exciting opportunity to join our team as a Senior Consultant in Electrical Safety (IEC 60601-1) and Design Controls, in the Medical Device Domain. As a senior consultant, you will be a part of an interdisciplinary group of consultants, leveraging your experience in medical device and/or IVD product development. With your knowledge in systems, electronics, embedded software, and/or mechanical design and development, you will be responsible for helping Qserve clients facilitate their business goals by (hands-on) help, assuring regulatory compliance for a wide range of medical devices, many of which are novel applications.
What you’ll bring to the team
The candidate we are looking for is a highly motivated and passionate Senior Electro/Mechanical/Embedded Software System Expert who has expertise in developing multi-disciplinary medical and/or in-vitro diagnostic devices. You have experience in design controls and meeting the IEC 60601-1 family of standards for safety and EMC. With your understanding of engineering development processes (specifications, verification, and validation) and your understanding of risk analysis (including usability and software), you are able to engage a large variety of medical and/or IVD device technologies and guide clients to successful global compliance. In this role, you must thrive on variety and be able to manage multiple projects. You must enjoy teaching and coaching and be able to effectively communicate technical subjects to both technical and non-technical people. We are a service-oriented organization so you must thrive on helping others. You must like to write. Some knowledge of the requisite regulatory requirements in the EU and the US is required. We are looking for someone who appreciates working on cutting-edge distributed systems and truly understands system engineering.
- A technical or scientific degree in a technical field;
- At least 5 - 7 years of working experience in electronic, mechanical, optical, and/or embedded software in the in-vitro diagnostics and/or medical device sector;
- Project experience that adhered to design controls;
- Direct experience with meeting the IEC 60601-1 standards;
- Communicative and service-oriented;
- Fluent in English;
- Working permit and driver's license.
Getting excited about a career in the dynamic and innovating world of medical devices? Then please submit your resume and motivation!
* This function will be executed remotely most of the time. We are open to candidates from the Netherlands, Germany, Belgium, France and the UK.
How we hire
Everything you need to know about your application process at Qserve Group
Getting to know you
In the first call, let our recruiter learn about you and your story to check a potential fit for Qserve. This is also a chance for you to ask first questions about the role and company.
In this meeting, your future manager takes a deeper dive into your experience and what you could bring to the team. Expect questions on how knowledgeable you are in your area of expertise.
You made it to the very last stage! Here we have a final call to ask some additional questions. This meeting will be between you, your future manager and a team member.
Is there a match? Then we will gladly make you an offer consisting of a suitable salary and our employment conditions. Do you accept our offer? Your adventure at Qserve Group will start!