Job Description

Wondering whats within Beckman Coulter?

Take a closer look.

Join a team where you can be heard, be supported, and always be yourself. At Beckman Coulter, a Danaher company, were building a culture that celebrates backgrounds, experiences, and perspectives of all our associates. We are dedicated to advancing and optimizing the laboratory to move science and health care forward for more than 80 years. We are invested in you and youll have the opportunity to build a meaningful career, be creative, and try new things with the support you need to be successful. Youll find the Danaher Business System, which makes everything possible.

At Beckman Coulter, at the heart of what we do, witness our shared purposehelping realize lifes potentialin action. Our work helps improve millions of lives.

We hope youll see yourself here, too.

What you find at Beckman Coulter and within yourself might just change the world!

This role is located in Chaska, MN, or Remote will be considered, and reports to the Manager of Development Quality Assurance. The Immunoassay product portfolio is diverse and includes new concepts for hardware, software, and immunoassay clinical decision applications.

This position will support the Development QA functional core team members in the software design and development life cycle of new products from initiation through market release in compliance with EIC 62304:2016 and internal BEC Software Development procedures.

This is a critical member of the Instrument Product Development Core and Design Change Team from the design progresses through the development process. Youll drive to achieve products that comply with Design controls requirements by using the Danaher Business System tools.





This role also includes the following 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 21CFR 820.30, Software as a Medical Device (SaMD) IEC 62304:2016, 62366-1:2015, ISO 13485, and ISO 14971
* Work cross functionally on defining performance requirements, conducting product and software risk analysis, reviewing verification and validation test plans, execution and data to complete the design transfers.





The essential requirements of the job include:

* Bachelors degree in Engineering or related technical field and 5+ years relevant working experience or Masters degree in same with 3+ years of experience or Doctoral degree in same with 0-2 years
* Design Assurance (QA) supporting product development projects in Quality Systems (Design Control) and Quality Design Assurance (DHF Compliance)
* Demonstrate experience in Quality oversight of product software and knowledge of EIC 62304:2016.
* Experience in a regulated industry such as medical devices, automotive or aerospace



This experience is a plus:

* Medical devices
* Product Software design assurance in accordance with 62304:2016

Beckman Coulter, a Danaher company, offers a broad array of comprehensive, competitive benefit programs that add value to associates and their families lives. Whether its a health care program or paid time off, our programs contribute to life beyond the job. Check out our benefits at danaherbenefitsinfo.com.

Accelerate your career while driving innovation that improves lives! Work hard and try new things, with guidance from committed leaders, powerful DBS tools, and the support of a global organization. As part of the Danaher family of 67,000 associates across the globe, your possibilities for growth and development are unparalleled.

We believe that creativity and innovation thrive when the most diverse set of voices are heard, and thats why were taking concrete steps to ensure that were fostering an inclusive and engaging workplace for our team. To learn more, read stories from our associates on our Careers Blog or contact one of our recruiters.

Danaher Corporation and all Danaher Companies are equal opportunity employers that evaluate qualified applicants without regard to race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. The EEO is the Law poster is available here.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

Danaher Corporation and all Danaher Companies are equal opportunity employers that evaluate qualified applicants without regard to race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. The EEO is the Law poster is available here.