Test Lead - Compliance, Quality and Regulatory

We are currently looking for a Functional Test Lead to our Compliance, Quality and Regulatory team (CQR) for a new exciting assignment within medical device development. The primary role of this position is to be responsible for timely planning and proper execution of test engineering in medical device development projects, based on identified and agreed needs to fulfil objectives on project level(s). 
The responsibility includes:  

•    Act as Functional Test Lead on device projects 
•    Execute Test Engineering Work Packages
•    Plan, execute, review and report on testing
•    Drive strategic improvement opportunities, establish best practice and share knowledge
•    Act as process or subject matter expert
•    Act as strategic test partner to client’s device project teams

Main job tasks
As Functional Test lead at Capgemini Engineering you will:
•    Act as functional test lead on device projects and represents Test Engineering and Test Execution teams in projects throughout the development process
•    Coordinate all deliverables with functional method validation leads and lab technicians and is accountable for project investigations
•    Execute test engineering packages and participate, contribute and provide input to specifications, project plans, protocols and reports etc
•    Identify and drive improvement opportunities, complex-solving and create new guidance
•    Ensure training for the test team in expertise areas
•    Lead and facilitate strategic test-related project decisions

As functional test lead you may also get the opportunity to act as Platform Test Lead for the client.

Your profile
We believe that you have a degree in Mechanical/Biomedical Engineering or related engineering discipline, with 2-5 years of experience of test engineering within medical device development including following aspects:
•    Tests and measurements
•    Verification of requirements
•    Data analysis & statistics
•    Test standards and regulations
•    Requirements engineering
•    Medical device design control 
•    Project management
•    Navigating a GMP-regulated environment
•    cLEAN
•    Business understanding and end-to-end mindset
•    Establishing and enabling strategy
•    Defining and driving process improvements or digitalization

You have a very good understanding of medical device regulations and standards, such as 21CFR820, ISO13485 and ISO17025 and a proven track record of successfully managing testing within medical device development projects. You are very good in communication and possess good leadership skills, with the ability to effectively collaborate with cross-functional teams, stakeholders, and external partners.
You are experienced in using different testing tools, processes and methodologies.

You are:
•    Fluent in written and spoken English. 
•    On an advanced level of coordination and communication,  
•    Proactively acting and ability to work independently. 
•    Curious and motivated by exciting challenges
•    A person who takes initiatives, is flexible and thrives in a dynamic environment, 
•    A person who finds it easy to cooperate and communicate with different groups of people, 
•    Genuinely interested in technology and problem solving,  
•    A strong Team player, and
•    Driven by challenges and personal development.