For our customer located in Basel St. Johann/Switzerland we are currently looking for a: System Engineer / Software Architect (m/f/d)
The Packaging and Medical Device Development team at our client is looking for an experienced System Engineer / Software Architect to lead the technical development of smart delivery systems. The ideal candidate contributes to the development of complex medical device and 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 requirement elicitation, system conceptualization, risk assessment, system verification and clinical validation.
Tasks & Responsibilities
- 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 project teams 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
- Excellent problem-solving skills with an analytical mind
- Software and Medical device design using UML/SysML 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
- Prior experience of integrating software modules developed by various team in the backend is highly desirable
- Knowledge of the best practices for software development: Methodology (Agile and V-Model) and tooling (CI/CD, Automation, Requirement Management, etc.)
- Experience with user experience, prototypes and proof of concept activities
- Experience with cyber security, data privacy and system performance requirements
- Bachelor or more advanced degrees in Biomedical Engineering, Systems Engineering, Electrical/Electronic 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 product development from concept to commercial launch
- Experience in modern cloud architecture with IoT is a big plus
- 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)
- Strong communication skills for both technical discussions with dev team and also for alignments with business stakeholders
Did we catch your interest?
The SimplyVision-Team is looking forward to receive your application (Word file is highly appreciated).
Kindly be informed that our customer is located in Switzerland. Therefore only applications from candidates within the EU or candidates holding Swiss work permission are required.