Beschreibung
We are looking for a Systems Engineer for a Global Medical Device company focusing on the development of new state of the art Combination/drug delivery devices. The System Engineer will contribute to the development of best-in-class system engineering practices and its implementation to medical device and/or software as medical device (SaMD) development projects. You will have practical experience covering the product development to the life cycle management. As an expert, you will work with cross-functional teams and support various development activities including system conceptualization, system requirements, risk assessment, system verification and validation.Responsibilities:
- Design and implement systems 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 systems engineering tool for requirement management and translate user and business needs into systems/sub-system requirements
- Actively maintain and monitor the traceability from the requirements to the verification activities
- Be the representative of systems 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
Academic Requirements:
- Bachelor or more advanced degrees in Biomedical Engineering, Systems Engineering, Electrical Engineering, Computer Science, or other relevant disciplines
Professional Requirements:
- 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)
Kontakt: Luchele Mendes
Michael Bailey International is acting as an Employment Business in relation to this vacancy.