Beschreibung
Network/System Analyst - System Engineer (Medical Device / Software as a Medical Device) m/fFor my client, a global leader in Life Science, I am currently looking for a specialist in System Engineering, with experience in covering the product development to the life cycle management and experience as a network architect for their medical device development projects. The expert will work with cross-functional teams and support various development activities including system conceptualization, system requirements, risk assessment, system verification and validation.
- Location: Basel, Switzerland
- Duration: Start mid July, 12 months with possible extension
- Departments: Packaging and Device Development (PDD) department
- Activities: Support the development and life cycle management of complex products as well as software as medical device
Network/System Analyst - System Engineer
Main 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 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 Qualification
The profile
- Bachelor or more advanced degrees in Biomedical Engineering, Systems Engineering, Electrical Engineering, Computer Science, or other relevant disciplines
- Minimum of 5 years experience in network architecture
- Knowledge in system functional modeling and/or programming ability using system modeling language (SysML) will be a plus
- Well-versed in medical product development, Quality Management System, and regulatory processes (ISO 13485; IEC 60601, 62304, 82304)
- Experience in developing and commercializing products using artificial intelligence or machine learning models is a strong advantage
- 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
Should you be interested in a project in Switzerland? Kindly get in contact with me and send me your updated CV to or give me a call on .
Sthree Switzerland is acting as an Employment Business in relation to this vacancy.