Description
We are currently looking for an experienced System Engineer / Software Architect in Basel (Switzerland) to join our team on client’s side. A great opportunity to work in the Pharma industry with exposure to new technologies, in an international environment.You will contribute to the development of software as medical device (SaMD) projects using state-of-the-art system engineering practices. This highly interactive role will work with cross-functional teams and support various development activities including system conceptualization, system requirement definition, risk assessment, system verification and clinical validation.
Major Accountabilities:
• 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
Requirements:
• Bachelor or more advanced degree in Biomedical Engineering, System Engineering, Electrical Engineering, Computer Science or other relevant disciplines
• 5+ years 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
• 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.Knowledge of system functional modeling and/or programming ability using system-modeling language (SysML) will be a plus
• Well-versed in medical device or SaMD development, Quality Management System, and regulatory processes (ISO 13485; IEC 60601, 62304, 82304)
• Good team player and excellent 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
• Candidates have to declare Criminal record extract not older than three months
We offer:
• Broad range of activities, tasks and projects
• Further development and professional advancement
• Friendly and international working environment
• Competitive salary and various benefits