
Senior Test Engineering Manager
5 days ago
We are currently looking for a highly skilled Functional Test Lead to join our Compliance, Quality and Regulatory team (CQR) in an 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 fulfill objectives at the project level.
Main Responsibilities
- Act as functional test lead on device projects and represent Test Engineering and Test Execution teams in projects throughout the development process
- Coordinate all deliverables with functional method validation leads and lab technicians and be accountable for project investigations
- Execute test engineering packages and participate, contribute and provide input to specifications, project plans, protocols, and reports
- 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
Your Profile
To be successful in this role, you will have a degree in Mechanical/Biomedical Engineering or a related engineering discipline, with 2-5 years of experience in test engineering within medical device development. Key aspects of your background should include 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, business understanding, end-to-end mindset, establishing and enabling strategy, defining and driving process improvements or digitalization.
You will also 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 skilled in communication and possess strong leadership abilities, with the capacity to effectively collaborate with cross-functional teams, stakeholders, and external partners.
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