Staff Software Quality Engineer

in St. Paul, MN

Staff Software Quality Engineer Job

Job Description Job Attributes+

  • Job ID


  • Req #


  • Job Location

    St. Paul, MN, US

  • Job Category


  • Job Type

    Full time

  • Travel

    Yes, 10 % of the Time

  • Schedule

    40 hours per week

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 115,000 colleagues serve people in more than 160 countries.

Staff Software Quality Engineer

Working at Abbott

At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. You’ll also have access to:

  • Career development with an international company where you can grow the career you dream of.

  • Free medical coverage for employees* via the Health Investment Plan (HIP) PPO

  • An excellent retirement savings plan with high employer contribution

  • Tuition reimbursement, the Freedom 2 Save student debt program and FreeU education benefit - an affordable and convenient path to getting a bachelor’s degree.

  • A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune.

  • A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists.

The Opportunity

This position works out of either our Plymouth or St Paul, MN location in the Structural Heart division.  Our business purpose is to restore health and improve quality of life through the design and provision of device and management solutions for the treatment of structural heart disease. This position is responsible for executing and maintaining software quality engineering methodologies and providing quality engineering support for software utilized throughout the division. The individual in this position will provide technical software quality leadership to the business unit and participate in the development of other technical contributors by facilitating training and providing feedback and guidance. This individual will have a unique opportunity to make a mark on the organization as a leader by creating, developing, and managing an effective team environment, while working on state-of-the art products.

What You’ll Work On:

  • Create and ensure on-time execution of Quality Plans for internal development, OEM-based, Clinical Product Development (CPDP), and design change projects and leading on-time completion of Project supported Quality Deliverables and business initiatives

  • Ensure DHF content integrity, completeness, and regulatory / standards compliance; collaboratively communicating & resolving gaps

  • Lead Risk Management activities from product Concept through Commercialization, focused on software related risks

  • Support and ensure the establishment of objective, measurable, discrete, and verifiable customer and system/software requirements

  • Support software verification activities traceable to system/software requirements

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

  • Support cybersecurity activities including threat modeling, security risk assessment, and post-market support

  • Support design test and inspection method development and validation activities

  • Support Design Verification and Validation planning & execution, including active cross-functional root-cause analysis investigation & resolution activities

  • Support and ensure internal & external audit responses and on-time product re-certifications

  • Develop and lead other team members

  • Ensure compliance to relevant FDA QSR, ISO guidelines, including 21 CFR Part 11 and Abbott Corporate requirements as they relate to the development, validation and maintenance of computerized systems.

Required Qualifications: 

  • Bachelor’s degree in Software Engineering, Computer Science, or a closely related discipline

  • 8+ years of Quality Engineering experience within new product development and demonstrated use of Quality tools/methodologies

  • Detailed knowledge of FDA, GMP, SDLC, IEC 62304, AAMI SW96, ISO 13485, and ISO 14971

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

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

  • Ability to travel occasionally (<5%), including internationally

Preferred Qualifications: 

  • 5+ years of prior medical device development experience

  • Experience working with different programming languages, such as, C, C#, C++, Python

  • Experience in application development within Linux

  • Familiar with embedded systems development and low-level hardware programming

  • Experience in the use/deployment of a requirements management environment, such as DOORS, Jama or Cognition Cockpit

  • Familiarity with or willingness to learn cloud computing resource development and deployment (Azure, AWS, etc.)

  • ASQ Certified Software Quality Engineer (CSQE) or Certified Quality Engineer (CQE) certification

  • Quality strategies and Reliability techniques for Software

* Participants who complete a short wellness assessment qualify for FREE coverage in our HIP PPO medical plan. Free coverage applies in the next calendar year.

Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives:

Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer, committed to employee diversity.

The base pay for this position is $90,700.00 – $181,300.00. In specific locations, the pay range may vary from the range posted.

Job Skills

  • software quality engineering
  • new product development (npd)
  • sdlc
  • python
  • iec 62304

Additional Information

Who We Are


Abbott values the leadership skills developed through military service and we have a broad range of functional areas to put your talents to work. Our organization is making a difference in the lives of the people we serve with a diverse offering of healthcare products. We have a strong veteran employee community to help with your transition from the military to the corporate world.

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