Abbott Engineer II, Software Quality in Plano, Texas

At Abbott, we're committed to helping you live your best possible life through the power of health. For more than 125 years, we've brought new products and technologies to the world -- in nutrition, diagnostics, medical devices and branded generic pharmaceuticals -- that create more possibilities for more people at all stages of life. Today, 94,000 of us are working to help people live not just longer, but better, in the more than 150 countries we serve. Please note that candidates need to be eligible to work in the U.S. without Abbott sponsorship.


This position is responsible for executing and maintaining quality engineering methodologies and providing quality engineering support for software utilized throughout Abbott.


  • Develop and conduct training of company personnel for the divisional software development and validation program.

  • Work with Design and NManufacturing Engineering in the completion of system/software requirements and other verification and validatiton processes.

  • Create and execute or direct software validation protocols traceable to system/software requirements.

  • Implement solutions for controlling code and administer Code Control and Software Event/Defect Tracking software systems.

  • Performs Software Configuration Management tasks.

  • Assist in the completion and maintenance of risk analysis, focused on software related risks.

  • Design and implement various product and process improvement methodologies (i.e, Six Sigma and Lean Manufacturing).

  • Apply sound, systematic problem solving methodologies in identifying, prioritizing, communicating and resolving issues.

  • Software scoping and Part 11 audits.

  • Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.

  • Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments. Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.

  • Performs other related duties and responsibilities, on occasion, as assigned.


  • BS Degree in Engineering or Technical Field or equivalent experience. ( Computer Engineering or Computer Science Degree preferred)

  • 2-5 years Software Quality Engineering experience.

  • Detailed knowledge of FDA, GMP, IEEE 1012 and ISO 13485. (Preferred knowledge of ISO 14971 and IEC 62304)

  • Advanced computer skills, including statistical/data analysis and report writing.

  • Advanced Information Technology and data mining skills.

  • Prior medical device experience preferred.

  • ASQ CSQE certification desired.

  • Experience working in a broader enterprise/cross-division business unit model preferred.

  • Ability to work in a highly matrixed and geographically diverse business environment.

  • Ability to work within a team and as an individual contributor in a fast-paced, changing environment.

  • Ability to leverage and/or engage others to accomplish projects.

  • Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization.

  • Multitasks, prioritizes and meets deadlines in timely manner.

  • Strong organizational and follow-up skills, as well as attention to detail.




ASJM Abbott St. Jude Medical


United States > Texas : 6901 Preston Road





Yes, 5 % of the Time




Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day), Keyboard use (greater or equal to 50% of the workday)

Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans.

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Abbott is about the power of health. For more than 125 years, Abbott has been helping people reach their potential — because better health allows people and communities to achieve more. With a diverse, global network serving customers in more than 150 countries, we create new solutions — across the spectrum of health, around the world, for all stages of life. Whether it’s next-generation diagnostics, life-changing devices, science-based nutrition, or novel reformulations, we are advancing some of the most innovative and revolutionary technologies in healthcare, helping people live their best lives through better health.

The people of Abbott come to work each day with relentless energy, enthusiasm and a promise to enhance the health and well-being of millions of people. They push the boundaries to help manage and treat some of life’s greatest health challenges.

We invite you to explore opportunities at Abbott , to see if your talents and career aspirations may fit with our openings. An equal opportunity employer, Abbott welcomes and encourages diversity in our workforce.

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