Beschreibung
For one of our Swiss Pharma clients we are looking for temporary support as:System Engineer Medical Devices (M/F/*)
Tasks:
• 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
Qualifications:
• Min. Bachelor degree in Biomedical Engineering, Systems Engineering, Electrical Engineering, Computer Science, or other relevant disciplines
• Min. 6 years of experience in Network Architecture
• Min. 5 years of experience in System Design with OS
• Expertise in cloud server / APP development
• Experience as a software architect in medical software
• 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 in working with the requirements and traceability management tools, e.g. SaMD
• Well-versed in medical product development, Quality Management System, and regulatory processes (ISO 13485; IEC 60601, 62304, 82304)
• Business Fluency in English
Nice-to-haves:
• Knowledge in system functional modeling and/or programming ability using system modeling language (SysML)
• Experience in developing and commercializing products using artificial intelligence or machine learning models
Frame Data:
• Start: asap
• Duration: 12 months
• Capacity: 40 h/week
• Location: Greater Basel, Switzerland