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.
As a Systems Engineer within the Cell and Gene Therapy global R&D organization at Cytiva, you will have the opportunity to join a passionate team of experts at automating biological cell processing. You will be responsible for improving the existing product portfolio in strong collaboration with cross-functional stakeholders by driving the design of new solutions through requirements elicitation and management, leading verification and validation planning and execution, ensuring traceability, and generating proper documentation consistent with our quality management requirements.
What you'll do
Manage requirements and traceability across the entire product lifecycle
Participate in development and improvement of existing products following our QMS
Drive verification and validation activities with focus on quality, compliance, and execution rigor
Formulate and lead the verification and validation test plan execution from proof-of-concept through final design
Lead the technical project roadmap involving proof-of-concept, design, manufacturing and V&V
Establish requirements acceptance criteria, asses through modelling or qualitative / quantitative testing with statistical rigor, and evaluate the performance
Close R&D collaboration with the project manager, engineering, and biology teams, taking the lead to translate between the parties to facilitate the achievement of a successful system
Work in close interaction with the Product Management, Production, Supply Chain, Quality, Marketing, external suppliers, and close to end-users (biotech or Pharma companies)
Mitigate project risks, deliver on-time, communicate effectively, resolve conflicts, and encourage constructive dialogue in project teams
Ensure compliance with ISO 13485 or ISO 9001 standards and other QMS requirements and take the lead on process optimization to avoid inefficiencies
Who you are
University degree or equivalent in related scientific or engineering fields (physics, mechatronics, mechanics, electronics, biomedical or similar fields)
10+ years of successful experience working in product development in a multidisciplinary environment, ideally involving broad HW/SW skills in engineering and in life science or medical fields
Experience in launching products to markets following a development cycle involving proof of concept, complex design, and verification & validation under a quality management system
Well-founded understanding of mechanical, electrical and software engineering disciplines, with preferably a good understanding of human cell biology and fluidics automation
Demonstrated ability to clearly communicate (oral, written) across global, cross-cultural, cross-functional teams and stakeholders
Knowledge and practical experience of relevant regulations (ISO 9001, ISO 13485, cGMP), specifically for the US and European market
Customer-oriented mindset, autonomous at work, good organizational skills, creative, and comfortable with change
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.