Application Sub-System V&V Engineer

The Application Sub-System V&V Engineer is critical to enabling Cytiva to maintain and develop high quality, robust systems used in the manufacture of Cell Therapies. With a focus on the Application sub-system, you will work closely with your colleagues focusing on hardware, disposable kits and software.

This position reports to the Senior Manager of the System V&V Team, is full-time and part of the Cell Therapy R&D Team located on-site in Signy, Switzerland.

What you will do:

• Responsible for verification of application interfacing with other subsystems (plan, procedures, tests execution) in compliance with system and sub-system requirements (URS, SRS, SSRS) to meet relevant regulatory standards, customers' expectations and to the highest QMS quality standards.
• Collaborate closely with System Engineering, System V&V lead, Application, Product Managers, Project Managers and Product Engineering to ensure all relevant system interfaces are considered and that the system functions effectively as a whole. Participate in the development of roadmaps, plans and priorities. When needed, participate in Applications team Scrum meetings (sprint planning, retro, standups).
• Collaborate and contribute to V&V deliverables of Applications sub-system (scope, strategy, plans, procedures, methods, tests, traceability matrices and reports). Actively participate in technical, design, and project reviews.
• Collaborate and contribute to Applications sub-system risk analysis deliverables, traceability of risks of Applications sub-system and system interfaces. Subject matter expert in verification and validation activities, sampling methods and risk analyses.
• Support failure investigations related to defects at the interface between System and Applications sub-system in collaboration with V&V Engineers, System Engineering, Project Managers, Product Engineering. Address and define way forward when gaps are identified in requirements, procedures, methods pertaining to development and V&V.

Do you have experience in Python?, Do you have a Master's degree?, * Master's degree in Systems Engineering, Computer Engineering, Life Sciences, Biomedical Engineering, or a related field.

• 6-8 years of experience in R&D within the life sciences or medical device industry.
• Proficiency in programming languages such as Java, Python, or C#.
• Familiarity with the software development lifecycle (requirements, design, implementation, testing, maintenance).
• Strong analytical skills and structured approach to problem-solving.

It would be a plus if you also possess previous experience in:

• Working with cell processing technologies or related biological systems.
• Knowledge of ISO 9001 and ISO 13485 standards.
• Using tools for risk management and product lifecycle documentation.

Are you ready to accelerate your potential and make a real difference within life sciences, diagnostics and biotechnology? At Cytiva, one of Danaher's 15+ operating companies, our work saves lives-and we're all united by a shared commitment to innovate for tangible impact. You'll thrive in a culture of belonging where you and your unique viewpoint matter. And by harnessing Danaher's system of continuous improvement, you help turn ideas into impact - innovating at the speed of life. Working at Cytiva means being at the forefront of providing new solutions to transform human health. Our incredible customers undertake life-saving activities ranging from fundamental biological research to developing innovative vaccines, new medicines, and cell and gene therapies. At Cytiva you will be able to continuously improve yourself and us - working on challenges that truly matter with people that care for each other, our customers, and their patients. Take your next step to an altogether life-changing career. Learn about the Danaher Business System which makes everything possible., Join our winning team today. Together, we'll accelerate the real-life impact of tomorrow's science and technology. We partner with customers across the globe to help them solve their most complex challenges, architecting solutions that bring the power of science to life.