Design Assurance Engineer (f/m/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 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.