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Danaher Corporation Senior Design Quality Assurance Engineer in Chaska, Minnesota

Wondering what’s within Beckman Coulter Diagnostics? Take a closer look.

At first glance, you’ll see that for more than 80 years we’ve been dedicated to advancing and optimizing the laboratory to move science and healthcare forward. Join a team where you can be heard, be supported, and always be yourself. We’re building a culture that celebrates backgrounds, experiences, and perspectives of all our associates. Look again and you’ll see we are invested in you, providing the opportunity to build a meaningful career, be creative, and try new things with the support you need to be successful.

Beckman Coulter Diagnostics is proud to work alongside a community of six fellow Diagnostics Companies at Danaher. Together, we’re working at the pace of change to improve patient lives with diagnostic tools that address the world’s biggest health challenges.

The Senior Quality Design Assurance Engineer for Beckman Coulter Diagnostics is responsible for the support of Development QA functional core team members in the design and development of existing and new products from initiation through market release with an objective to provide high quality, reliable, and regulatory compliant products to market. You’ll drive to achieve products that comply with Design controls requirements by using the Danaher Business System tools.

This position is part of the Development Quality Assurance department located in Chaska, MN and will be a hybrid of on-site (Chaska) and remote work.

You will be a part of the Instrument Product Development Core and Design Change Team and report to the Manager Development Quality Assurance. If you thrive in a fast-paced role and want to work to build a world-class Development Quality Assurance organization—read on.

In this role, you will have the opportunity to:

  • Collaborate with Development Quality Assurance to ensure that product Design History File documentation is compliant to the FDA and international regulations

  • Adhere to company procedures as well as to FDA QSR, ISO, IEC 62304 and other global regulations

  • Work cross functionally on defining performance requirements, conducting risk analysis, reviewing verification and validation test plans, execution and data to complete the design transfers.

The essential requirements of the job include:

  • Bachelor’s degree in Engineering or related technical field and 5+ years relevant working experience; or Master’s degree in same with 3+ years of experience; or Doctoral degree in same with 0-2 years

  • Experience in Design Assurance (QA) supporting product development projects in Quality Systems (Design Control) and Quality Design Assurance (DHF Compliance)

  • Experience in a regulated industry such as medical devices, automotive or aerospace

It would be a plus if you also possess previous experience in:

  • Medical devices

  • Software design assurance

Danaher is committed to a diverse and inclusive culture where everyone feels they belong and all voices are heard. We believe in our associates and the unique perspectives they bring to every challenge, which is why we’ll empower you to push the boundaries of what’s possible.

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 (https://www.danaher.com/how-we-work/danaher-business-system) tools and the stability of a tested organization.Danaher Corporation and all Danaher Companies are committed to equal opportunity regardless of race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. 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.The EEO posters are available here (https://www.dol.gov/agencies/ofccp/posters) .We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform crucial job functions, and to receive other benefits and privileges of employment. Please contact us at 202.419.7762 or applyassistance@danaher.com to request accommodation.If you’ve ever wondered what’s within you, there’s no better time to find out.

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