Currently hiring for a Systems Engineer based in Basel for an initial 12 months contract within the pharmaceutical area.
Design and implement system engineering approach to support the development and life cycle management of complex products and platforms in the areas of connected drug delivery devices, digital technologies, and SaMD.
Demonstrate strong technical know-how at system level and guide the development team to use structured system engineering approach for product development.
Author relevant design history files and GMP compliant documentations.
Prior experience with design control processes, product lifecycle management in a GMP environment
Good knowledge in systems engineering approach and risk-based approach for product development
Experience working with the requirements and traceability management tools
Knowledge in system functional modelling and/or programming ability using system modelling language (SysML) will be a plus.
Experience in developing and commercializing products using artificial intelligence or machine learning models is a strong advantage
Well-versed in medical product development, Quality Management System, and regulatory processes (ISO 13485; IEC 60601, 62304, 82304)
Please submit with updated CV if interested, alternatively email me upon Michael Bailey International is acting as an Employment Business in relation to this vacancy.