Systems Engineer (m/f/d)

Work Selection; Risch-Rotkreuz; Vor Ort; CHF 100.000 - 140.000; Vollzeit

Benefits dieser Stelle

Vielfalt und Chancengleichheit

Moderne Campusumgebung

Fortbildungsmöglichkeiten

Zusammenfassung

Work Selection sucht in Rotkreuz für Roche Diagnostics einen Systems Engineer. Die Stelle ist befristet bis Ende 2027 mit hoher Verlängerungschance und Fokus auf Systementwicklung komplexer Diagnosesysteme aus Fluids, Software und Sensorik.

Sie übernehmen Requirements Engineering, Schnittstellenmanagement und MBSE-Ansätze, arbeiten eng mit HW/SW, Operations, Regulatory Affairs und Clinical Development zusammen und treiben die Integration verschiedener Systemkomponenten voran.

Qualifikationen

• Erfahrung in einem regulierten Umfeld, ideal im IVD(Bereich).
• Mindestens 3–5 Jahre praktische Erfahrung in Systemdefinition, Requirements Engineering und Systems Thinking.
• Fundierte Kenntnisse der System-Engineering-Methoden und mehrerer Technologiebereiche (Elektronik, Mechanik, SW).
• Gegliederte, strukturierte Arbeitsweise und gute Kommunikationsfähigkeiten.
• Englisch mindestens CEFR L2/B2.

Aufgaben

• Verantwortung für Requirements Engineering und -Elicitation sowie Requirements Management.
• Koordination des Requirements-Change-Control-Prozesses.
• Beitrag zu Dokumenten wie Product/Technical Requirements, Traceability, Product Risk Analysis und Configuration Management.
• Mitwirkung bei FMEA und Risikoanalysen.
• Unterstützung der Systemtests in Design Verification und Validation.
• Interne Schnittstelle zu HW/SW, Operations, Customer Support, Regulatory Affairs und Clinical Development.

Kenntnisse

Systemdefinition

Requirements engineering

Systems thinking

Elektronik

Mechanik

Software

Englisch B2

Ausbildung

Bachelor/Master in Mechatronics / Mechanical/Electrical Engineering / Biomedical Engineering

Tools

SysML

Enterprise Architect

Jobbeschreibung

As a first-tier supplier to our renowned business partner Roche Diagnostics in Rotkreuz, we are currently looking for a motivated and dedicated Systems Engineer for a temporary assignment until the end of 2027, with high probability of extension.

Roche is shaping the future of critical care diagnostics. Blood gas und electrolyte (BGE) analysis is used in critical point-of-care settings where time and quality matter. NPC RundD BGE is responsible for the development of new and improved BGE analysis systems and the life cycle maintenance of existing BGE products. Within NPC RundD, System Development and Integration is where everything comes together: a team of dedicated scientists, engineers, and lab technicians ensures that hardware and software fit together seamlessly with sensor and reagent technologies to form robust and reliable BGE analysis systems.

The company is looking for a new team member in their Systems Engineering group to help ensure the development success of their complex diagnostics systems, consisting of fluidics, software, instruments, biochemical sensors, and reagents. In this role, you will own and manage system-level topics and documentation, mainly in the form of requirements engineering, interface management, conceptual work, and change control management. Furthermore, you will support the alignment and integration of different system components using Model-Based Systems Engineering and champion the use of agentic AI in requirements engineering.

The Perfect Candidate for this role possesses a background in development within a regulated environment, preferably in the IVD(R) sector, and has 3-5 years of practical experience in system definition, requirements engineering, and systems thinking. They should demonstrate a strong grasp of systems engineering methodologies and an understanding of multiple technology domains, including electronics, mechanics, and software. Additionally, the candidate should exhibit a clear and structured working style, proactive collaboration skills, and the ability to maintain both a big-picture perspective and attention to detail.

Tasks und Responsibilities

Core Systems Engineering und Requirements

• 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
• Support system testing during design verification and validation activities

Cross-Functional Integration und Collaboration

• Facilitate interface management and descriptions
• Align and coordinate with affected parties across all systems engineering topics
• 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

Innovation: AI und Model-Based Systems Engineering (MBSE)

• Ideate and develop LLM agents or similar AI use cases for design, system performance, and documentation analysis to improve systems engineering artifacts and processes
• Drive alignment between component development and integration into one system via interface definitions and MBSE methodologies

Must-Haves

• Background in development within a regulated environment, ideally in the IVD(R) area
• Min. 3-5 years of practical experience in system definition, applying requirements engineering skills, acting as a systems thinker, and focusing on the "big picture"
• 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)
• Pragmatic approach to problem-solving
• Strong team player
• English - Advanced CEFRL B2

Nice-To-Haves

• Experience combining systems engineering methodologies with artificial intelligence
• INCOSE or IREB certification
• Practical experience with SysML in general or Enterprise Architect in particular
• Experience in the system integration of complex multidisciplinary systems
• Bachelor / Master (BSc/MSc) in Mechatronics, Mechanical/Electrical Engineering, Physics, Biomedical Engineering, Biotechnology, natural sciences, or equivalent
• Ability to challenge the status quo and work unsupervised
• German CEFRL B2

Benefits

• Become part of one of the most prestigious pharmaceutical companies and actively shape the future of healthcare
• Experience a work culture that promotes diversity and inclusion and where all employees feel valued
• Work on a state-of-the-art campus featuring green spaces, meeting areas, and an inspiring atmosphere
• Work with modern and up-to-date tools in an innovative work environment
• Start with a professional onboarding process and a thorough introduction to your new role during the Welcome Days
• Benefit from financial support for your professional development plans
• Enjoy a selection of high-quality meals in modern staff restaurants
• As part of a sustainable mobility concept, on-site parking spaces are available to you (subject to eligibility criteria)
• Take advantage of unbeatable, year-round discounts at renowned retailers and over 200 top brands
• Benefit from fleet discounts when purchasing new cars or receive constant fuel discounts with our fuel card

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