Beschreibung
For one of our Swiss Pharma clients we are looking for temporary support as:System Engineer / Software Architect 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:
• Bachelor or more advanced degrees in Biomedical Engineering, Systems Engineering, Electrical Engineering, Computer Science, or other relevant disciplines
• Minimal 5 years of experience in medical device, or other highly regulated industry
• Prior experience covering the medical device or SaMD development from concept to commercial launch
• Experience working with the requirements and traceability management tools
• Well-versed in medical device or SaMD development, Quality Management System, and regulatory processes (ISO 13485; IEC 60601, 62304, 82304)
• Software and System design using UML diagrams with good abstraction skills
• Expertise in Web and Mobile application design, development and testing
• Experience with Cloud and IoT architecture and technologies for complex systems
• Knowledge of best practices for software development: Methodology (Agile and V-Model) and tooling (CI/CD, Automation, Requirement Management, etc.)
• Experience with research, prototypes and PoC activities
• Experience with cyber security and performance requirement
• Business Fluency in English
Frame Data:
• Start: asap, 01.12.2019 the latest
• Duration: 12 months
• Capacity: 40 h/week onsite
• Location: Basel Area, Switzerland