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RORoche Diagnostics Int. AG

Systems Engineer(m/w/x)

Risch-Rotkreuz
Part-timeOn-siteExperienced
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System requirements management for diagnostics products, ensuring consistency across PRQ, TRQ, and USP levels. Deep knowledge in requirements visualization and peer reviews required. Documentation and traceability management, with product risk assessment experience.

Requirements

  • Deep knowledge in managing system requirements
  • Experience with requirements visualization
  • Experience with requirements peer reviews
  • Use of industry-standard management tools
  • Proven track record in product risk assessments
  • Managing configuration baselines
  • Experience within a structured quality management system
  • Adept communicator
  • Supervising other engineers
  • Managing stakeholder relationships
  • Managing project team relationships
  • Ensuring testability
  • Ensuring alignment
  • Commitment to implementing divisional standards
  • Applying change control processes
  • Escalating deviations
  • Ensuring continuous improvement
  • Experience working across functions
  • Integrating inputs from various engineering disciplines
  • Creating cohesive system models

Tasks

  • Lead requirements elicitation, analysis, and validation
  • Ensure consistency across PRQ, TRQ, and USP levels
  • Support colleagues in defining use cases and constraints
  • Manage documentation, tracing, and change management
  • Maintain milestone documentation and traceability
  • Oversee Requirements Change Board and Scope Board
  • Lead impact analyses for change proposals
  • Manage external partners by creating specifications
  • Review work results from external partners
  • Drive risk assessments and manage the Risk Management Plan
  • Ensure all mQMS deliverables are met
  • Partner with Configuration Managers to identify configuration items
  • Maintain physical instrument configuration history
  • Track configuration baselines
  • Coordinate with HW Engineering, SW Engineering, Operations, and Customer Support
  • Review system models to ensure integrated concepts
  • Identify process improvement areas for requirements management
  • Apply best practices in requirements management
  • Uphold department and divisional standards

Work Experience

  • approx. 1 - 4 years

Education

  • Bachelor's degreeOR
  • Master's degree

Languages

  • English – Business Fluent

Tools & Technologies

  • industry-standard management tools
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Roche Diagnostics Int. AG and processed the information on Nejo with the help of AI for you. Despite careful analysis, some information may be incomplete or inaccurate. Please always verify all details in the original posting! Content and copyrights of the original posting belong to the advertising company.

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