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Requirement Engineer- IVD/Medical Devices/German
Eingestellt von ITech Consult
Gesuchte Skills: Engineering, Engineer, Support
Projektbeschreibung
REQUIREMENT ENGINEER IVD/MEDICAL DEVICES/ENGLISH
ROLE PURPOSE:Our client is looking for a Required Engineer with strong experience 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).
-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 (Writternthus we understand what it means to be professionally supported in your search for a new project and being employed.
ROLE PURPOSE:Our client is looking for a Required Engineer with strong experience 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).
-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 (Writternthus we understand what it means to be professionally supported in your search for a new project and being employed.
Projektdetails
Geforderte Qualifikationen
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Kategorie:
Ingenieurwesen/Technik, Sonstiges