SaMD Network/System Analyst - System Engineer
Posted on Aug 25, 2020 by RM IT Professional Resources AG
System Engineer/Software Architect vacancy for our Basel based globally operating client in the pharmaceutical sector.
- Minimum 5 years of experience in medical device or other regulated industry with expertise in Web and Mobile application design using UML/SysML diagrams, development and testing
- Sound knowledge of the best methodologies (Agile and V-Model) and tools (CI/CD, Automation, Requirement Management) for software development, along with experience with user experience, prototypes and proof of concept activities
- Strong understanding of Cloud and IoT architecture and technologies for complex systems, as well as experience with cyber security, data privacy and system performance requirements
- Proficiency in medical device or SaMD development, Quality Management System, and regulatory processes (ISO 13485; IEC 60601, 62304, 82304)
- Previous experience in carrying out full-cycle expansion of medical device or SaMD development
- Bachelor or higher degree in Biomedical Engineering, Systems Engineering, Electrical Engineering or other relevant disciplines
- Languages: English, fluent in written and spoken
- Designing and implementing 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
- Demonstrating strong technical know-how at system level and guiding the project teams for product development
- Utilizing the system engineering tool for requirement management and translating user and business needs into system/sub-system requirements
- Maintaining and monitoring the traceability from the requirements to the verification activities
- Being the representative of system engineering team for the communications with cross-divisional teams, programs, and stakeholders
- Managing external vendors for development, as well as taking the lead on technical discussions
- Authoring relevant design history files and GMP compliant documentations
- Supporting various development activities including system conceptualization, system requirement definition, risk assessment, system verification and clinical validation
Does this Spark your interest? Then take the next step by sending us your CV as a Word document and a contact telephone number on which you are reachable during working hours.
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