Requirement Engineer - IVD/Diagnostics/CPRE/IREB/CCBA

REQUIREMENT ENGINEER: IVD/DIAGNOSTICS/CPRE/IREB/CCBA/IIBA/MEDICAL DEVICES/ENGLISH

ROLE PURPOSE:Our client is looking for a Required Engineer with a background in IVD development.

Job Responsibilties & Requirements:

- Should have at least 5 years of experience working as a Requirements Engineer in Diagnostics Environment.
- Should have at least 5 years of experience handling the multiple projects on the whole development process.
- Good experience working in regulated environment and functions and dependencies in IVD development.
- Responsible for elicitation of customer and internal stakeholder requirements.
- Responsible to cooperate with usability engineering in process analysis.
- Leadership to drive cross functional team alignment and support of team decisions in engineering process.
- Responsible to transfer of product requirements into technical and software requirements in cooperation with receiving department (instrument, reagent, software development)
- Documentation and change management of requirements
- Contribution to assessment of changes and its impact on technical and software requirements
- Responsible to support of product risk assessment.

IT Skills:

- Good experience in application management tools (ideally HP ALM), tools for analysis, interpretation of data and visualization (like MS access, visio, office)
- Strong analytical thinking, ability to see the big picture as well as the details (ia separation of requirements, breakdown structures)
- Should have good experience in moderating peers and stakeholders.

Education:

- Bachelor/Master (BSc/MSc) in Engineering, Biotechnology or equivalent.
- Knowledge of engineering approaches and tools (Application Lifecycle Management Tools).
- Certification in CPRE/IREB and/or CCBA/IIBA (foundation level/capability level).

Languages:

- Fluent in English (Writternhence we well understand what it means to be professionally supported in your search for a new project and being employed.