Engineer II - Software Design Assurance

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 114,000 colleagues serve people in more than 160 countries.

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.

• Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year

• 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 our Pleasanton, CA office in our Heart Failure division. In Abbott’s Heart Failure business, we’re developing solutions to diagnose, monitor and manage heart failure, allowing people to restore their health and get on with their lives.

As the Engineer II, Software Design Assurance you will responsible for supporting product development by executing software quality engineering tasks and providing quality engineering support for software. This junior-level position emphasizes document reviews, traceability analysis, and risk tracing activities. Note: This role focuses on software design quality and regulatory compliance. It is not a Software QA or Test Engineering function.

What You’ll Work On

• Review traceability between software requirements and test cases.

• Support tracing of risks and ensure appropriate documentation is maintained.

• Review software development documentation including plans, protocols, and reports.

• Participate in meetings to discuss and review issues captured in problem resolution systems.

• Support risk evaluation activities such as FMEA and product risk analysis.

• Assist in technical reviews to ensure design deliverables are met.

Support validation activities for non-product software as needed.

• Maintain compliance with US FDA regulations, other country regulatory requirements, company policies, and procedures.

• Collaborate with cross-functional teams, especially R&D.

• Support audits and quality system improvement activities.

• Additional responsibilities may be assigned as needed.

Required Qualifications

• Master’s degree in engineering or Technical Field with 0 to 1 year of experience, or

• Bachelor’s degree in engineering or Technical Field with minimum 2 years of related work experience.

• Basic understanding of regulations, standards, and guidance affecting medical software development.

• Strong verbal and written communication skills.

Preferred Qualifications

• Previous experience in quality engineering or use of quality tools/methodologies.

• Experience working in a cross-functional team environment.

• Knowledge of Software Development Lifecycle (SDLC) processes

• Knowledge of basic Risk Management concepts

Apply Now (

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.

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The base pay for this position is $79,500.00 – $138,700.00. In specific locations, the pay range may vary from the range posted.

An Equal Opportunity Employer

Abbot welcomes and encourages diversity in our workforce.

We provide reasonable accommodation to qualified individuals with disabilities.

To request accommodation, please call or email