Engineer II Software Design Assurance

Abbott Laboratories • Pleasanton, CA

78d • $79,500 - $138,700

About The Position

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.

Requirements

• 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.

Nice To Haves

• 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.

Responsibilities

• 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.

Benefits

• Career development with an international company.
• 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.
• A company recognized as a great place to work in dozens of countries.
• Named one of the most admired companies in the world by Fortune.
• Recognized as one of the best big companies to work for as well as a best place to work for diversity.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Industry: Computer and Electronic Product Manufacturing
• Education Level: Master's degree