Contract : permanent with AKKA Switzerland
On behalf of our global client based in Basel area, we are actively looking for a System Engineer
- 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
- Utilize the system engineering tool for requirement management and translate user and business needs into system/sub-system requirements
- Actively maintain and monitor the traceability from the requirements to the verification activities
- Be the representative of system engineering for the communications with cross-divisional teams, programs, and stakeholders
- Manage external vendors for development and lead the technical discussions with the vendors
- Author relevant design history files and GMP compliant documentations
YOUR PROFILE :
- Bachelor or more advanced degrees in Biomedical Engineering, Systems Engineering, Electrical Engineering, Computer Science, or other relevant disciplines
- 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 modeling and/or programming ability using system modeling 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)
- A good team player, and problem solver with strong analytical mind
- Strong communication skills to both lead the technical discussions with vendors and also align with internal stakeholders to drive decisions
If this sounds like your next challenge could you please send me your updated CV at / (+41 78 929 78 14) and I will call you to discuss it in more details.
Alternatively, if you think this position could benefit someone you know, please do not
hesitate to fwd it and cc.