Dein persönlicher KI-Karriere-Agent
Systems Engineer(m/w/x)
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.
Anforderungen
- 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
Aufgaben
- 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
Berufserfahrung
- ca. 1 - 4 Jahre
Ausbildung
- Bachelor-AbschlussODER
- Master-Abschluss
Sprachen
- Englisch – verhandlungssicher
Tools & Technologien
- industry-standard management tools
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Systems Engineer(m/w/x)
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.
Anforderungen
- 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
Aufgaben
- 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
Berufserfahrung
- ca. 1 - 4 Jahre
Ausbildung
- Bachelor-AbschlussODER
- Master-Abschluss
Sprachen
- Englisch – verhandlungssicher
Tools & Technologien
- industry-standard management tools
Gefällt dir diese Stelle?
BetaDein Career Agent findet täglich ähnliche Jobs für dich.
Über das Unternehmen
Roche Diagnostics Int. AG
Branche
Pharmaceuticals
Beschreibung
The company is dedicated to advancing science and ensuring access to healthcare for everyone, with a focus on innovative diagnostics solutions.
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