Working at Cytiva in the Life Sciences industry 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. With associates across 40 countries, Cytiva is a place where every day is a learning opportunity – so you can grow your career and expand your skills in the long term.
Cytiva is proud to work alongside a community of nine fellow Danaher Life Sciences companies. Together, we’re pioneering the future of science and medicine, developing products that enable researchers in the fight to save lives.
We are looking for a R&D - Sr. Verification and Validation Engineer to work with our expert Cell and Gene Therapy Disposables R&D team of more than 30 employees across the world. Do you have a passion for developing products which will influence the future of medical technologies? Then we would love to hear from you.
What you’ll do
Assess product specifications or change controls for improving the robustness, usability or the manufacturing of new and existing devices.
Write project technical specifications, execute development and perform verification and validation activities with focus on quality, compliance and execution rigor.
Derive test requirements from the specifications, define test plan and methodology, estimate effort and resources plan to cover design verification and validation campaign.
Set-up design of experiments (DOE) and perform verification and validation activities, and/or review plan and results within the R&D Disposables kit team, with focus on quality, compliance and execution rigor.
Establish acceptance criteria, sampling, assess through modelling or qualitative/quantitative testing, evaluate the performance.
Develop good practice guidelines for performing disposables kit verification and validation activities and organize standardization and harmonization within the R&D disposables team.
Learn, master and ensure harmonization in the team of usage of tools used for development, verification and validation and project management.
Perform and document technical root cause investigation in close R&D collaboration with hardware, software, application and disposable kit system matter experts.
Work in close collaboration with other R&D team members, Suppliers, Production, Supply Chain, Quality and Product Management.
Mitigate project technical risks, resolve issues, deliver on-time and communicate effectively.
Who you are
Master’s degree or equivalent in related scientific or engineering fields (mechanics, micro-mechanics).
Minimum 10 year-experience in designing, developing and manufacturing plastic disposable kit products for regulated industry (medical device, class II and/or class III).
Well-founded knowledge and practical experience of relevant regulations (ISO13485, FDA 21 CFR Part 820), specifically for the US and European market product submission.
Demonstrated experience in defining and managing verification and validation plan, execution, statistical data analysis and report.
Experience in verification activities related to disposable kits for medical device application associated to manufacturing processes as injection molding, compression molding, tube extrusion, thermoforming, heat staking, ultrasonic welding, laser welding, snap-fitting, UV gluing, solvent bonding.
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 C1 in English).
Self-starter, hands-on, creative problem solver and solution developer when presented with conflicting requirements, business demands and technical risks/issues.
Knowledge of plastic biocompatibility, leachable & extractable and sterilization techniques is a plus.
When you join us, you’ll also be joining Danaher’s global organization, where 69,000 people wake up every day determined to help our customers win. As an associate, you’ll try new things, work hard, and advance your skills with guidance from dedicated leaders, all with the support of powerful Danaher Business System tools and the stability of a tested organization.
At Danaher, we value diversity and the existence of similarities and differences, both visible and not, found in our workforce, workplace and throughout the markets we serve. Our associates, customers and shareholders contribute unique and different perspectives as a result of these diverse attributes.
If you’ve ever wondered what’s within you, there’s no better time to find out