Application V&V Engineer (m/f/d)

Radiometer; Schweiz; On-site; CHF 140,000 - 190,000; Full time

Job summary

Cytiva in Switzerland is seeking an experienced Application V&V Engineer to drive verification and validation across subsystems, ensuring regulatory compliance and product readiness for life sciences applications.

You will lead test strategies, own artifacts, collaborate with multidisciplinary teams, and mentor junior engineers, contributing to continuous improvement and robust product quality within a Danaher-connected environment.

Qualifications

• Master’s degree in Systems Engineering, Computer Engineering, Life Sciences, Biomedical Engineering, or a related field.
• 10+ years in new product development and manufacturing science in life sciences or medical devices.
• Proven V&V strategy execution experience.
• Strong knowledge of the software development lifecycle and regulatory requirements.
• Fluent in English.

Responsibilities

• Lead and deliver System and Application V&V activities, including scope, plans, methods, procedures, test execution, traceability, risk management, and reporting.
• Own V&V outputs: test protocols, execution records, traceability matrices, verification and validation reports, risk control verification evidence, and investigation reports.
• Collaborate with System Engineering, Biology, Application, Software, Quality, Product Management, Project Management, and Product Engineering teams to ensure all relevant system interfaces are considered and that the product performs effectively as an integrated system.
• Contribute to product roadmaps, project plans, and priorities, and participate in Agile development activities as needed, including sprint planning, backlog refinement, retrospectives, and daily stand-ups.
• Serve as the subject matter expert (SME) for Verification & Validation (V&V), providing expertise in test methodologies, sampling strategies, risk-based approaches, and regulatory-compliant V&V practices.
• Actively contribute to technical design reviews, project reviews, and cross‑functional discussions to ensure robust verification strategies and product quality.
• Support the investigation and resolution of defects, failures, and requirement gaps, particularly at System and Application subsystem interfaces, working with cross‑functional teams to identify root causes and define effective corrective actions.
• Provide technical mentorship to Application V&V engineers and promote the consistent application of V&V best practices.
• Drive continuous improvement of System V&V activities through the optimization of processes, tools, methodologies, and ways of working.

Skills

V&V

Test methodologies

Regulatory compliance

ISO 9001

ISO 13485

cGMP

Java

Python

C#

English

Education

Master’s degree in Systems Engineering or related field

Job description

Bring more to life. 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.

The Application V&V Engineer (m/f/d) is responsible for the verification and validation of applications interfacing with multiple subsystems, ensuring that all functional, performance, and integration requirements are met in accordance with applicable regulatory standards, customer expectations, and the organization’s highest Quality Management System (QMS) standards. This position reports to the System V&V Manager and is part of the System Verification & Validation team, based in Signy (Switzerland). The role is on-site and supports Cytiva’s Cell Therapy Business Unit within the R&D organization.

What you will do:

• Lead and deliver System and Application Verification & Validation (V&V) activities and deliverables, including defining scope, strategies, plans, methods, procedures, test execution, traceability, risk management, and reporting.
• Own key V&V outputs such as test protocols, execution records, traceability matrices, verification and validation reports, risk control verification evidence, and investigation reports.
• Collaborate closely with System Engineering, Biology, Application, Software, Quality, Product Management, Project Management, and Product Engineering teams to ensure all relevant system interfaces are considered and that the product performs effectively as an integrated system.
• Contribute to product roadmaps, project plans, and priorities, and participate in Agile development activities as needed, including sprint planning, backlog refinement, retrospectives, and daily stand-ups.
• Serve as the subject matter expert (SME) for Verification & Validation (V&V), providing expertise in test methodologies, sampling strategies, risk-based approaches, and regulatory-compliant V&V practices.
• Actively contribute to technical design reviews, project reviews, and cross‑functional discussions to ensure robust verification strategies and product quality.
• Support the investigation and resolution of defects, failures, and requirement gaps, particularly at System and Application subsystem interfaces, working with cross‑functional teams to identify root causes and define effective corrective actions.
• Provide technical mentorship to Application V&V engineers and promote the consistent application of V&V best practices.
• Drive continuous improvement of System V&V activities through the optimization of processes, tools, methodologies, and ways of working.

Who you are:

• Master’s degree in Systems Engineering, Computer Engineering, Life Sciences, Biomedical Engineering, or a related field.
• 10+ years of experience in new product development, product care, project management, and manufacturing science & technology, preferably in the medical device or life sciences industry involving cross-functional teams.
• Proven expertise in defining, planning, and executing Verification & Validation (V&V) strategies and activities.
• Strong knowledge of the software development lifecycle, including requirements, design, implementation, testing, and maintenance.
• Solid understanding of product lifecycle management and regulatory requirements, including ISO 9001, ISO 13485, and cGMP for US and European markets.
• Strong analytical and problem‑solving skills, with proficiency in programming (e.g., Java, Python, C#) and a results‑driven, autonomous, and innovative mindset.
• Excellent communication and stakeholder management skills, with experience collaborating across global, cross‑functional, and multicultural teams; fluent in English.

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

• Broader System V&V experience beyond Application and Software is a plus, ideally including exposure to mechanical, electrical, or biomedical subsystems, to strengthen cross‑system knowledge and support robust impact assessments.

Cytiva, a Danaher operating company, offers a broad array of comprehensive, competitive benefit programs that add value to our lives. Whether it’s a health care program or paid time off, our programs contribute to life beyond the job. Check out our benefits at Danaher Benefits Info.

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.

For more information, visit www.danaher.com. Danaher is a leading global life sciences, biotechnology, and diagnostics innovator, helping to solve many of the world’s most important health challenges, ultimately improving quality of life for billions of people today, while setting the foundation for a healthier, more sustainable tomorrow. The Danaher ecosystem is made up of more than 15 businesses united by a shared commitment to innovate for tangible impact.

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