Beschreibung
For our client in Basel we are looking for a System Engineer for Packaging and Device Development for a 12-month contract.
Job title: System Engineer for Packaging and Device Development
Duration: ASAP to
Location: Basel
Workload: 100%
Description:
The Packaging and Device Development (PDD) department 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 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 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
. Author relevant design history files and GMP compliant documentations
. Work within development projects with cross-functional teams, provide the system-level views and guide the projects to use the structured approach for product development
Must haves:
* Bachelor or more advanced degrees in Biomedical Engineering, Systems Engineering, Electrical Engineering, Computer Science, or other relevant disciplines
. Prior experience with design control processes, product life cycle management in a GMP environment
. Expert knowledge in Systems Engineering and Risk Management
. Experience working with detailed requirements and traceability in order to author requirement documentations
. Knowledge in system functional modelling and/or programming ability using system modelling language (SysML) is highly preferred.
. Well-versed in medical product development, Quality Management System, and regulatory processes (ISO 13485, 60601, 62304)
For further details please contact:
Anna Undas
(see below)