Beschreibung
Senior Requirements Engineer and Product Risk Manager - engineering/MedTech/CPRE/ASEP/GermanProject / Role:
For our partner Roche Diagnostics in Rotkreuz we are looking for a highly motivated and qualified Senior Requirements Engineer and Product Risk Manager (f/m/d)
Background:
Within RDS R&D Network Core Lab Instrumentation Development, the Product Definition Teams (PDT) for Hematology, Coagulation & Legacy ensure in close collaboration with our business functions the comprehensive understanding of customer needs in this business segment and its translation into requirements for our future Core Lab platforms and their updates over their product life cycle.
We are looking for a Senior Requirements Engineer with proven track record in Product Risk Management. An ideal candidate possesses a well-rounded background of functions and dependencies of all system components of IVD systems or medical devices or has gained experience in systems engineering of complex system such as automotive or aerospace.
Main Tasks
Requirements Engineering (elicitation, analysis, elaboration, validation) within complex projects and Product Risk Management
* Create understanding of need and rational of customer requirements in close collaboration with business functions
* Support the project scope process and provide clarity of required features and functions to the respective stakeholders
* Plan and drive cross functional alignment, team decisions around the elaboration of requirements and fit of technical solutions to create customer value
* Manage requirements (documentation, tracing)
* Create and manage respective Design and Change Control deliverables
* Drive assessment of changes to technical and software requirements with special focus on suitability to overall system capabilities
* Lead and guide the risk management process with the designated team (product risk assessment, elaboration of product risk control measures and respective traceability and documentation)
* Report status of product risk management activities to the project leader / product responsible person
* Use efficiently Application Management Tools and continuously support improving Requirements Engineering practices.
Must Have:
* B.Sc/M.Sc in Engineering or Life Science, for example in MedTech, aerospace or automotive
* 5-7 years of working experience in multiple complex system projects over the whole development process, including product lifecycle
* 5-7 years of working experience in requirements engineering (Hardware and Software requirements), respective regulation and tools (as example but not limited to: HP ALM and RETINA/Intland Codebeamer)
* 5-7 years of working experience in product risk management
* 5-7 years of working experience in product development
* Certification in CPRE/IREB and/or CCBA/IIBA, or ASEP (INCOSE)
* Business fluency in English spoken and written, German would be an advantage
* Analytical thinking with ability to see the big picture as well as the details
* Curious to understand complex structures and behaviors
* Good communication skills, patience and tenacity
* Ability to lead, follow-up and work well in multidiscipline teams
Reference No.: 920608SGR
Role: Senior Requirements Engineer and Product Risk Manager
Industry: Pharma
Location: Rotkreuz
Workload: 100%
Start: 01.10.2021
Duration: 12++
Deadline: 07.09.2021
Should you find yourself suitable for this position then please send us your complete CV using the link in this advert. If the position is not a perfect match and you wish to receive other opportunities directly, you can send us your CV anyway via this advert or to jobs[at]itcag[dot]com.
Contact us for further information regarding our company, our positions or our attractive payroll-only-program: .
About us:
ITech Consult is a certified ISO 9001:2015 Swiss company with offices also located in Germany and Ireland. ITech Consult is specialised in delivering IT candidates for contract work. We were founded in 1997 by IT professionals; hence we well understand what it means to be professionally supported in your search for a new project and being employed.