OverviewSenior Manager, Verification & Validation is responsible for managing a Verification & Validation (V&V) team and has accountability for the performance and results of the team. Lead and develop a team of 5–10 people with internal and external resources with expertise in full product life cycle and in-depth capabilities in verification and validation, fostering a culture of quality and compliance.This position reports to the Director, PjM and System and is part of the Cell Therapy R&D Department located in Grens and will be an on-site role.You’ll thrive in a culture of belonging where you and your unique viewpoint matter. 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.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. For more information, visit www.danaher.com.What you will do
Ensure development of hardware, software, and disposables complies with QMS, FDA Design Controls, MDD, and EU MDR standards.
Manage product evaluations from prototype to verification and validation, delivering high-quality risk management files and reliability studies.
Promote Design for Reliability & Manufacturability (DRM) practices and actively contribute to design and technical reviews.
Apply problem-solving tools such as Six Sigma, Lean, and root cause analysis; understand sampling techniques.
Support DHF remediation to meet EU MDR requirements, including risk assessments, standards testing, and usability engineering.
Ensure robust execution of V&V protocols and documentation for both new and legacy products.
Contribute to quality system activities including audits, CAPA, non-conformities, and complaint investigations requiring design updates.
Who you are
10+ years of experience in Medical Device Industry, with a proven ability to deliver compliant, high-quality products in a regulated environment. Deep expertise and practical experience of relevant regulations and standards
Minimum 5+ years of experience building and leading high-performance teams in a global environment.
Experience with the full product lifecycle of mechano-fluidic products with minimum 10+ years experience in managing V&V activities including, planning, risk management (PFMEA, DFMEA), execution, and documentation (reports, traceability matrix).
Experience in design verification and validation activities, including biocompatibility, extractables & leachables (E&L), bioburden, endotoxin (LAL), aging, packaging.
Skilled in statistical methods, statistical process control, sampling plans, and familiar with reliability analysis and test methods (as t-test, Anova, linear regression, tolerance intervals, DOE).
Travel, Motor Vehicle Record & Physical/Environment Requirements
Ability to travel up to 25%
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