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 R\&D Technical Lead- Associate Senior R\&D Engineeris responsible for leading all activities required to be supported by the DK R\&D team.
This position reports to Sr Manager, I, SUT System Engineering and is part of the Cell Therapy R\&D Department located in Grens and will be an on-site role.
What you will do:
Overall design, development and design transfer responsibility of the disposable kits during execution of new product or legacy product engineering projects. Make sure that a complete solution is designed where all included parts, sub-assemblies, sterile finished good or products are contributing to meet the customer expectations and product specifications (URS, SRS).
Ensure that applicable customer URS requirements are tracked and fulfilled. Regulatory fulfilment of delivered products.
Represent Cytiva in technical discussions with customers and notified bodies. Coordinate the detailed design and solve any issues during the design phase.
Coordinate and approve the product design verification and validation activities during development phase. Coordinate and approve the design transfer activities for NPI performed through CMOs and/or done internally. Support design transfer activities when it relates to legacy product engineering activities.
Chair technical design reviews and meetings, be able to identify and solve technical risks and problems. Support project manager in the planning of product development activities.
Support quality audits by providing engineering and technical support, when requested. Follow up of strategic suppliers providing plastic components such as injection molding, extrusion components or bags and cryo-bags.
Work in a multidisciplinary Research and Development team, in close interaction with the production, Supply Chain, Quality and Sales \& Marketing departments, as well as end-users and suppliers.
Who you are:
Master’s degree or equivalent in related scientific or engineering fields (mechanics, plastics, material sciences, biomedical engineering or micro-mechanics).
15+ year-experience in designing, developing and manufacturing plastic disposable kit products or equivalent for regulated industry (medical device, class II and/or class III), including the documentation associated to URS, SRS, design FMEA and V\&V.
Very well-founded knowledge and practical experience of relevant regulations (ISO13485, FDA 21 CFR Part 820), specifically for the US and European market product submission.
Experience in manufacturing processes development (e.g. rapid prototyping technologies, injection molding, compression molding, tube extrusion, thermoforming, heat staking, heat sealing, ultrasonic welding, laser welding, snap-fitting, UV gluing, solvent bonding) associated with a medical device or biological application, including the whole documentation related to FAT, SAT, IQ, DOE \& characterization, OQ, PQ, process FMEA, Gage R\&R, Cpk process capability, SPC.
Strong organizational and communication skills in multisite, multidisciplinary, multicultural matrix organization. Fluent in written and spoken English and French mandatory (minimum C1 in French and English)
Customer focus and results driven, deliver on time and constantly meet customer expectations.
Quality First culture, design product for reliability and manufacturability. Six Sigma Certification (Green Belt, Black Belt) or knowledge of DFSS.
Travel, Motor Vehicle Record \& Physical/Environment Requirements:
Ability to travel up to 10%
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.