Description
System Engineer - Digitalized Medical DevicesWe have an excellent contract opportunity for a Systems Engineer who will contribute to the development of next generation digitalized medical devices and software as medical device (SaMD). The preferred candidate has practical experience covering the product development to the life cycle management. The expert 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 system engineering approach to support the development and life cycle management of complex products and platforms in the areas of connected embedded 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
Requirements:
- Masters 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 modelling 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)
- Strong communication skills to both lead the technical discussions with vendors and also align with internal stakeholders to drive decisions
Kontakt: Luchele Mendes
Michael Bailey International is acting as an Employment Business in relation to this vacancy.