Senior SW Quality Assurance Engineer in Chaska, Minnesota at Beckman Coulter Diagnostics

Date Posted: 11/5/2019

Job Snapshot

Job Description

Job ID: BEC015271

About Us

Beckman Coulter develops, manufactures and markets products that simplify, automate and innovate complex biomedical testing. Our diagnostic systems, found in hospitals and other critical care settings around the world, produce information used by physicians to diagnose disease, make treatment decisions and monitor patients. Scientists use our life science research instruments to study complex biological problems including causes of disease and potential new therapies or drugs. More than 275,000 Beckman Coulter systems operate in both diagnostics and life sciences laboratories on all seven continents. For 80 years, our products have been making a difference in peoples’ lives by improving the productivity of medical professionals and scientists, supplying critical information for improving patient health and reducing the cost of care.
Beckman Coulter offers a broad array of comprehensive, competitive benefit programs that add value to associates' and their families' lives. Whether it's a health care program or paid time off, our programs contribute to life beyond the job. Check out our benefits. We think you'll like what you see.
If you believe your education and experience are in line with the position description and qualifications referred to above, and are motivated, energetic, and looking for a new and exciting opportunity, please submit your resume online at the URL below or at www.beckmancoulter.com.
Beckman Coulter is an equal opportunity employer.  We evaluate qualified applicants without regard to race, color, national origin, religion, gender, age, marital status, disability, veteran status, sexual orientation, gender identity, or any other characteristic protected by law.


Description

  • Fulfill the Development QA role for Product Software Development Teams as the design progresses through the development process. Understand the product software design/process life cycle and ensure the creation of documented evidence of compliance to Beckman Quality System and applicable regulatory requirements.
  • Collaborate effectively with other Dev QA, developers and other functional group team members in defining performance requirements, conducting risk analysis, and verification test plan execution. Drive to achieve Design for Reliability results by effective use of applicable Danaher Business System tools.
  • QA support to Beckman software product development projects in areas of Quality Systems (Design Control) and Quality Assurance (DHF compliance).
  • Work with other Dev. QA to complete assigned project, procedural, assessments, or data analysis task or as delegated to quality function specialists within the organization.
  • Contribute to overall success of the project schedule and accomplishment of QA function deliverables to the project. 
  • Ensure that assigned task are compliant to Beckman applicable procedural requirements as well as to FDA QSR, IE 62304:2016; ISO 13485, and other global regulations
  • Design Control:  Complete tasks related to completion of Design Input documents, Verification & Validation data review, Risk Management, Design Transfer, and other associated Dev. QA function deliverables.
  • Quality Assurance:  Effective interaction with members of the Dev. QA function to ensure that product Design History File documentation is organized, complete per applicable procedure, and compliant to the FDA and international regulations. 
  • Process and Procedure Improvement:  Complete tasks related to supporting Dev. QA process and procedure improvement initiatives. 

Job Requirements



Qualifications

  • Bachelor Degree in Software Engineering, or BS in Engineering or in related technical field with minimum 5+ years of experience or Master’s degree in the field with 3+ years of experience or Doctoral degree in the field with 0-2 years.
  • Demonstrated knowledge of software system risk assessment, modular design concepts, software verification testing, and software requirements development and traceability.
  • Fluent in English language
  • Proficient in word processing, electronic documentation systems, spreadsheets, and project management tools
  • Well-developed skills in writing, review documentation, and oral communication within a technical team. 
  • Ability to influence decisions within Dev QA function and across functions within product line or project.
  • Experience in a regulated industry specifically knowledge of IVD and Medical Device industry
  • Ability to support several projects simultaneously while effectively adapting to changing project parameters
  • Mobility Requirements: Stand/Sit/Walk 8 hrs. /day; ability to travel across campus and between facilities.
  • Dexterity Requirements: Able to use computer & monitor to develop, review and communicate job-related documentation.
  • Vision requirements: Correctable to 20/20 in 1 eye and 20/40 in other eye.  Able to use computer & monitor to develop, review and communicate job-related documentation.
  • Hearing requirements: Able to participate in meetings and conference calls and to use a telephone.


Diversity & Inclusion
At Danaher, we are dedicated to building and sustaining a truly diverse and inclusive culture. These are not just words on a page—Diversity and Inclusion is a top priority for the company, and it ties deeply to each of our core values. Danaher Corporation and all Danaher Companies are equal opportunity employers that evaluate 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.


Danaher Corporation Overview

Danaher is a global science & technology innovator committed to helping our customers solve complex challenges and improve quality of life worldwide. Our world class brands are leaders in some of the most demanding and attractive industries, including life sciences, medical diagnostics, environmental and applied solutions. Our globally diverse team of 71,000 associates is united by a common culture and operating system, the Danaher Business System, which serves as our competitive advantage. We generated $19.9B in revenue last year. We are ranked #162 on the Fortune 500 and our stock has outperformed the S&P 500 by more than 5,200% over 25 years.
At Danaher, you can build a career in a way no other company can duplicate. Our brands allow us to offer dynamic careers across multiple industries. We're innovative, fast-paced, results-oriented, and we win. We need talented people to keep winning. Here you'll learn how DBS is used to shape strategy, focus execution, align our people, and create value for customers and shareholders. Come join our winning team.
Danaher is committed to competitive compensation that typically has key components including base salary, variable annual incentive compensation based on personal and company performance, and long-term incentive.