System Engineer/Software Architect
System Engineer/Software Architect - Basel
Jocelyn Blackham is recruiting for a System Engineer/Software Architect to join a company in the Medical Device industry at their site based in Basel on a contract basis for 12 months, with the possibility of extension.
This role will sit in the Packaging and Device Development (PDD) department focusing on 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.
The main purpose of the role will be to:
- 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.
Further responsibilities will include:
- Be the representative of system engineering for the communications with cross-divisional teams, programs, and stakeholders.
- Author relevant design history files and GMP compliant documentations.
In order to be considered for this role, you will be required to have the following qualifications, skills and experience:- Experience with Cloud and IoT architecture and technologies for complex systems.
- Experience with research, prototypes and PoC activities.
- Bachelor or more advanced degrees in Biomedical Engineering, Systems Engineering, Electrical Engineering, Computer Science, or other relevant disciplines.
- Prior experience covering the medical device or SaMD development from concept to commercial launch.
- Well-versed in medical device or SaMD development, Quality Management System, and regulatory processes (ISO 13485; IEC 60601, 62304, 82304).
This is an excellent opportunity to join a leading medical device and pharmaceutical industry.
For more information or to apply for this position, please contact Jocelyn Blackham on 0041 (0) 782 516 595 or email jblackham@ckqls.ch. Please could you send any correspondence in English. Please quote reference 46936 in all correspondence.
