The system engineer is responsible for the requirements definition, the traceability of the deliverables along the development cycle, for the design reviews lead, technical support to the project / product manager, the development and test teams.
Define the product development requirements according to high-level marketing requirements and regulatory constraints.
Provide support to the project managers during the design phase to reach deadlines, cost, and quality goals.
Ensure that the interactions between the various sub-systems (biological products, instruments, software’s) are clearly defined.
Ensure that the requirement management process is followed and ensure a formal link between the marketing and development teams.
Contribute to establish integration, verification, and validation plans.
Propose / participate to technical design choices.
Organize and lead the design reviews.
Participate on the DHF (Design History File) definition and its achievement in line with normative environment.
Be involved in the project / product risk analysis.
Contribute to innovation and technology survey.
You hold a Master Degree Master in biology / biomedical or an equivalent qualification in engineering.
You have 5 to 10 years in Systems Engineering or on Software / Hardware specification, development, Verification & Validation of complex systems.
It will be a plus if this experience has been acquired in an In Vitro Diagnostic (IVD) company.
Knowledge of System development including SW and HW; of automation and associated softwares; of laboratory automate functions
Knowledge of CE IVD or FDA regulation for SW and HW development will be a plus for the position.
Ability to work in an international environment and to travel occasionally.
Minimum a first experience with transverse management between interdisciplinary teams
You are fluent in English and have good French knowledge.
Do you see your next professional challenge in this position? We look forward to receiving your application. If you click on "Apply", you have the option of submitting your complete cover letter, resume and credentials in a coherent PDF or Word document .
To all recruitment agencies : Bio-Rad does not accept agency resumes, unless the agency has been authorized by a Bio-Rad Staffing Representative.
Please do not submit resumes unless authorized to do so. Bio-Rad will not pay for any fees related to unsolicited resumes.