We are looking for an experienced Systems Engineer who will contribute to the development of best-in-class system engineering practices and its implementation to the development of new state of the art medical device and software as medical device (SaMD) projects. You will have practical experience covering the product development through to the life cycle management. You will work with cross-functional teams and support various development activities including system conceptualization, system requirements, risk assessment, system verification and validation.
* Design and implement system engineering approach to support the development and life cycle management of complex products and platforms in the areas of drug delivery devices, digital technologies, and SaMD.
* 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
* Author relevant design history files and GMP compliant documentations
* Work within development projects with cross-functional teams, provide the system-level views and guide the projects to use the structured approach for product development
* Advances degree 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
* Expert knowledge in Systems Engineering and Risk Management
* Experience working with detailed requirements and traceability in order to author requirement documentations
* Knowledge in system functional modeling and/or programming ability using system modeling language (SysML) is highly preferred.
* Well-versed in medical product development, Quality Management System, and regulatory processes (ISO 13485, 60601, 62304)
Please contact Luchele Mendes on +41 (0) 44 215 2051
Michael Bailey International is acting as an Employment Business in relation to this vacancy.