Beschreibung
Medical Devices/Smart Delivery Systems - IoT - SaMD
#15592 | 12 month+ contract | Switzerland
James Carrera at Umbilical has partnered with a Global Pharmaceutical client to source an experienced Software Engineer/Architect to support Medical Device Development, in particular lead the technical development of Smart Delivery Systems projects using state-of-the-art system engineering practices.
Accountable for:
Working cross-functional you will support various development activities including requirement elicitation, system conceptualization, risk assessment, system verification and clinical validation;
- 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.
- Utilize the system engineering tool for requirement management and translate user and business needs into system/sub-system requirements
- Actively maintain/monitor the traceability from the requirements to the verification activities
- Represent system engineering for the communications with cross-divisional teams, programs, and stakeholders
- Manage external vendors for development leading the technical discussions with the vendors
- Author relevant design history files and GMP compliant documentations
Qualifications:
Educated to degree or advanced degree in Biomedical Engineering, Systems Engineering, Electrical/Electronic Engineering, Computer Science, or other relevant disciplines, also;
- 5 years of experience in medical device, or other highly regulated industry
- Medical device or SaMD product development from concept to commercial launch
- Software/Medical device design using UML/SysML diagrams
- Strong technical know-how at system level to guide project teams for product development
- Expertise in Web and Mobile application design, development and testing
- Cloud and IoT architecture and technologies for complex systems
- Knowledge of the best practices for software development: Methodology (Agile and V-Model) and tooling (CI/CD, Automation, Requirement Management, etc.)
- Well-versed in medical device or SaMD development, Quality Management System, and regulatory processes (ISO 13485; IEC 60601, 62304, 82304)
For a confidential discussion, contact James Carrera at Umbilical
Reference ID: 15592
Contract length: 12 months
Job Types: Full-time, Contract