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System Engineer - Medical Product Development (Consultant)
Engineering - Leuven | Just now
We are looking for an experienced System Engineer to join our team in Leuven, to support the development of a radically innovative testing solution for airborne infectious diseases, such as SARS-CoV-2. You will assist in defining the product requirement and in technically steering both internal and external development teams. As the liaison between the Imec scientists and the development partners, you understand the whole system: from user needs level all the way to lower level requirements. Further on, you will create system verification protocols and will be in charge of the verification activities. You are able to report your progress in crystal-clear reports and you play a crucial role creating the Design Control documentation.
You will report to the system engineering lead to accomplish tasks that are instrumental to the success of this project. Also see https://www.imec-int.com/en/expertise/life-sciences/coronavirus-breathalyzer
System Engineer - Medical Product Development (Consultant)
The assignment
- Act as liaison between the Imec scientists and the external development partners.
- Track technical progress and assess the impact of design changes.
- Create system-level and lower-level requirements as well as other Design Control documents like risk analysis, human factors, design reviews and more.
- Create verification plans and protocols and execute the tests.
Required knowledge and skills
- You hold an MSc in Engineering or equivalent, with at least 2 years of experience working in medical device development.
- Experience in creating Design Control documentation in an ISO 13485 quality management system is a strong bonus.
- Experience with managing external parties is a strong bonus.
- You have a statistical mindset and know how to set statistical test criteria in place.
- Both hands-on mentality and system thinking are required.
- A team player with excellent communication skills and fluent in English.
Duration of the assignment
Minimum 6 months
Desired startdate and work regime
Asap - fulltime
Location
imec Leuven