Design Assurance Engineer (f/m/d)

Reposted 22 Hours Ago
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Grens, Vaud, CHE
In-Office
Junior
Biotech
The Role
The Design Assurance Engineer ensures quality support for new product implementations and manufacturing transfers, while enhancing QA processes and compliance.
Summary Generated by Built In

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%.

#LI-MK2

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 (or higher) degree in engineering or health sciences field
  • Minimum 2-3 years' experience in an ISO 9001, medical device or pharmaceutical industry
  • Demonstrated understanding of product development lifecycles
  • Ability to read and interpret professional journals, drawings, and technical procedures
  • QA process knowledge and experience with device/instrument hardware
  • Proficiency with Microsoft tools
  • Excellent verbal, written, and presentation skills in English and French

Cepheid Compensation & Benefits Highlights

The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Cepheid and has not been reviewed or approved by Cepheid.

  • Leave & Time Off Breadth PTO and paid holidays are portrayed as robust, with formal programs and mentions of generous time off and rollover in some cases. This breadth supports a positive view of time-off availability.
  • Healthcare Strength Core medical, dental, and vision coverage is highlighted repeatedly and is viewed as comprehensive for regular full‑time employees. Descriptions such as “good” or “great” benefits reinforce the strength of the health coverage.
  • Retirement Support A 401(k) plan with company matching is consistently included as part of the package. The presence of matching contributions strengthens perceived retirement readiness.

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The Company
HQ: Sunnyvale, CA
4,883 Employees
Year Founded: 1996

What We Do

Cepheid is dedicated to improving healthcare by pioneering molecular diagnostics that combine speed, accuracy, and flexibility. The company's GeneXpert® systems and Xpert® tests automate highly complex and time-consuming manual procedures, providing A Better Way for institutions of any size to perform world-class PCR testing. Cepheid’s broad test portfolio spans respiratory infections, blood virology, women’s and sexual health, TB and emerging infectious diseases, healthcare-associated infectious diseases, oncology and human genetics. The company’s solutions deliver actionable results where they are needed most – from central laboratories and hospitals to near-patient settings. For more information, visit http://www.cepheid.com.

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