Application V&V Engineer (m/f/d)
About the role
Application V&V Engineer (m/f/d)
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 .
#LI-AC1 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 .
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Skills
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