Systems Engineer: Regulated S&D & AI Integration (Remote)

Flexsis; Risch-Rotkreuz; Hybrid; CHF 120.000 - 160.000; Vollzeit

Benefits dieser Stelle

Home Office 20%

Zusammenfassung

Flexsis, a member of the Interiman Group, is assisting Roche Diagnostics in Rotkreuz to identify a reliable and motivated professional for a structured, regulated environment starting 01.10.2026. The role centers on requirements engineering across HW/SW domains, with heavy collaboration across Operations, Regulatory Affairs, and Clinical Development to ensure traceability and robust documentation.

The ideal candidate will drive requirements elicitation, change control, and risk analysis, while

Qualifikationen

• Background in development within a regulated environment, ideally in the IVD(R) area.
• Min. 3-5 years of practical experience in system definition and requirements engineering.
• Fundamental knowledge of relevant methodologies used in systems engineering.
• Experience with and understanding of multiple technology domains (e.g., Electronics, Mechanics, and SW).
• Clear and structured working style with excellent communication skills.
• Proactive mindset that promotes collaboration within interdisciplinary teams.
• Analytical thinking; ability to see both the big picture and the details (e.g., separation of requirements, work breakdown structures).

Aufgaben

• Own Requirements Engineering and Elicitation as well as Requirements Management.
• Drive and coordinate the requirements change control process.
• Contribute to and author development documents, such as: Product/Technical requirements, Traceability analysis (verification), Product risk analysis, and configuration management.
• Collaborate heavily during FMEA and risk analysis/assessments.
• Cooperate cross-functionally with HW and SW Engineering, Operations, Customer Support, Clinical Development and Medical Affairs, and Regulatory Affairs.
• Collaborate during the definition, planning, and execution of project tasks and work packages.
• Ideate and develop LLM agents or similar AI use cases for design, system performance, and documentation analysis to improve systems engineering artifacts and processes.

Kenntnisse

Requirements Engineering

Systems Thinking

Big Picture

Analytical Thinking

Communication

Tools

FMEA

Risk Analysis

Jobbeschreibung

Flexsis, a member of the Interiman Group, is assisting Roche Diagnostics in Rotkreuz to identify a reliable and motivated professional for a structured, regulated environment starting 01.10.2026. The role centers on requirements engineering across HW/SW domains, with heavy collaboration across Operations, Regulatory Affairs, and Clinical Development to ensure traceability and robust documentation.

The ideal candidate will drive requirements elicitation, change control, and risk analysis, while