Lead Design Assurance Engineer (m/f/d)

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 Lead Design Assurance Engineer for Cytiva is responsible for ensuring compliance to Quality Assurance processes during product development, new product implementation including transfer of work and other Quality Assurance related projects as needed.

This position is part of the Quality Assurance department at our Signy manufacturing site located in Grens (Vaud) and will be on site. At Cytiva, our vision is, to advance future therapeutics from discovery to delivery.

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 to ensure excellence and compliance in project execution through effective project management and inter-department collaboration.

• Plan, create and manage the overall Quality Planning strategy for new product transfer and implementation and other Quality Assurance related projects as needed.

• Review requirements, specifications and technical design documents to provide timely and meaningful feedback.

• Manage Quality Assurance inputs to validation protocols, reports and investigate the causes of non-conforming validation activities.

Who you are:

• Bachelor’s (or higher) degree in engineering or health sciences field or other related degree.

• Minimum 7-10 years’ experience in an ISO 9001, medical device or pharmaceutical industry preferably in Quality Design Engineering related role with an experience of device/instrument hardware and software and any experience in single use disposable kits.

• 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 life science environment.

• Ability to manage projects and lead by influence.

• Excellent verbal, written, and presentation skills with the ability to communicate business issues clearly in English and French.

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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.

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