System Engineer vacancy requiring profound product development knowledge for a globally operating Basel based company in the pharmaceutical sector.
- 5+ years’ experience with System Design and Network Architecture including a background in design control processes and product lifecycle management in a GMP environment
- Familiarity with risk-based and system engineering approach for product development along with requirements and traceability management tools practice
- Knowledge of system functional modelling coupled with programming skillset preferably using system modelling language
- Experience in product development and commercialisation using artificial intelligence and machine learning is a major advantage
- Strong understanding of medical product development, quality management system, and regulatory processes including ISO 13485; IEC 60601, 62304 and 82304
- Ability to lead technical discussions with vendors and align with stakeholders to drive decisions
- Degree in Biomedical Engineering, Systems Engineering, Electrical Engineering, Computer Science or other relevant field of study
- Languages: fluent English both written and spoken
- Designing and implementing the system engineering approach to support development and life cycle management of complex products and platforms in the fields of connected drug delivery devices, digital technologies, and software as medical devices
- Implementing technical expertise at system level and directing the development team to use a structured system engineering approach
- Using the system engineering tool for requirement management and translating user and business needs into system and sub-system requirements
- Maintaining and monitoring the traceability from requirements to verification activities
- Representing system engineering in communications with teams, programs and stakeholders that act cross divisional
- Managing external vendors and leading the technical discussions with them
- Creating GMP compliant documentations and relevant design history files
Location: Basel, Switzerland
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