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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.
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The Design Assurance Engineer is responsible for QA Design activities for new product implementation, transfer of manufacturing and other QA related projects as needed.
This position is part of the Quality Department located in Grens in Switzerland (VD) and will be an on-site role.
What you will do:
Provide quality support and coordinates activities for collaboration programs with third parties and new product introductions NPIs and transfer of manufacturing projects.
Create detailed, comprehensive and well-structured change control strategy and records · Review requirements, specifications and technical design documents to provide timely and meaningful feedback.
Support the development, implementation, and continuous improvement of manufacturing process and Quality Systems.
Write, review and approve all new site documentation ensuring compliance with QMS.
Suggest solutions to identified site problems to ensure consistent project execution.
Develops process improvement plans using a variety of Quality and Continuous Process Improvement tools, including but not limited to Process Mapping, Six Sigma, Lean Manufacturing, 5S, SPC, RCA, engineering studies, DOE, Gauge R&R, etc.
Identifies and reports any EHS, Quality or Compliance concerns and takes immediate corrective action or escalation as required.
Who you are:
Bachelor’s (or higher) degree in engineering or health sciences field or other related degree.
Minimum 2-3 years’ experience in an ISO 9001, medical device or pharmaceutical industry in an Engineering, Quality or Regulatory or R&D related role.
Demonstrated understanding of product development lifecycles, design change, document change control, process verification and validation methodologies, manufacturing/production process control methodologies, and servicing in a medical device environment.
Ability to read and interpret professional journals, drawings, and technical procedures.
Solid QA process knowledge with an emphasis on technical skills to ensure understanding of technical data and information; experience of device/instrument hardware and software and any experience in single use disposable kits is desirable.
Proficient with Microsoft tools; Word, Excel, Power Point, Project, Minitab, and Visio.
Excellent verbal, written, and presentation skills with the ability to communicate business issues clearly in English and French language (spoken and written).
Travel, Motor Vehicle Record & Physical/Environment Requirements:
Ability to travel up to 10%.
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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.
Skills Required
- Bachelor's degree in engineering or health sciences field or related degree
- Minimum 2-3 years' experience in ISO 9001, medical device or pharmaceutical industry
- Understanding of product development lifecycles and design change methodologies
- Ability to read and interpret technical journals and documents
- Proficient with Microsoft tools
- Excellent verbal and written communication skills in English and French
Beckman Coulter Diagnostics Compensation & Benefits Highlights
The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Beckman Coulter Diagnostics and has not been reviewed or approved by Beckman Coulter Diagnostics.
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Healthcare Strength — Healthcare coverage is described as comprehensive, including medical, dental, vision, life and disability insurance, flexible spending accounts, and mental health support. Feedback suggests these offerings are a notable strength of the overall package.
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Leave & Time Off Breadth — Paid time off, paid holidays, sick days, and volunteer time are highlighted, with flexibility or remote arrangements available for some roles. Feedback suggests this breadth of time-off options contributes meaningfully to total rewards.
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Parental & Family Support — Paid parental leave is provided for birth, adoption, or foster placement with the ability to use time in flexible increments within the first year. Feedback suggests family-focused perks like adoption support add tangible value for caregivers.
Beckman Coulter Diagnostics Insights
What We Do
Beckman Coulter is committed to advancing healthcare for every person by applying the power of science, technology, and the passion and creativity of our teams to enhance the diagnostic laboratory’s role in improving healthcare outcomes. Our diagnostic systems are used in complex biomedical testing, and are found in hospitals, reference laboratories and physician office settings around the globe. Beckman Coulter offers a unique combination of people, processes and solutions designed to elevate the performance of clinical laboratories and healthcare networks. We do this by accelerating care with a menu that matters, bringing the benefit of automation to all, delivering greater insights through clinical informatics and unlocking hidden value through performance partnership. An operating company of Danaher Corporation since 2011, Beckman Coulter is headquartered in Brea, Calif., and has more than 11,000 global associates working diligently to make the world a healthier place.
