Posted on Sep 6, 2019 by Harvey Nash IT Recruitment Switzerland
For our client in Basel we are looking for System Engineer for 6-month contract.
Job title: System Engineer
Duration: ASAP to 14/07/2020
Our client is looking for an experienced System Engineer. The System Engineer will contribute to the development of best-in-class system engineering practices and its implementation to medical device and/or software as medical device (SaMD) development projects. The preferred candidate has practical experience covering the product development to the life cycle management. The expert will work with cross-functional teams and support various development activities including system conceptualization, system requirements, risk assessment, system verification and validation.
The primary responsibilities of System Engineer include:
* 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
* Bachelor or more advanced degrees in Biomedical Engineering, Systems Engineering, Electronic Engineering, Computer Science, or other relevant disciplines
* Track record of going through the product development cycle, from prototype to commercial launch, in the medical device industry or GMP environment is highly valued
* Good knowledge in systems engineering approach and risk-based approach for product development
* Experience working with the requirements and traceability management tools
* Knowledge in system functional modelling and/or programming ability using system modelling language (SysML) will be a plus.
* Experience in developing and commercializing products using artificial intelligence or machine learning models is a strong advantage
* Well-versed in medical product development, Quality Management System, and regulatory processes (ISO 13485; IEC 60601, 62304, 82304)
* A good team player, and 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
- understanding of medical device standard/regulations (ISO13485, 21 CFR part 820, IEC 62304)
- practical experience working in Medtech industry.
- strong technical expertise in one of the engineering fields or technical areas mentioned above in JD.
- specialized and able to provide technical leadership in one of the following areas: cloud/Back End server architecture, AI/ML algorithms, software/APP development as medical device (SaMD)
- ability to architecting the system, define the interface between sub-systems and coordinate the overall project activities at technical level
Additional Requirements needed:
- expertise in cloud server/APP development in medical device field or other regulated environment, experience as a software architect in medical software
For further details please contact: