Staff Engineer, Design Assurance- Software

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.

     

JOB DESCRIPTION:

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 onsite out of our Pleasanton, CA, Burlington, MA or Atlanta GA locations in the Abbott Heart Failure Division Global Design Quality Department.  

In Abbott’s Heart Failure (HF) business, we’re developing solutions to diagnose, monitor and manage heart failure, allowing people to restore their health and get on with their lives.

We are seeking an experienced Staff Engineer, Software Design Quality to ensure our medical devices are developed in accordance with Abbott’s design control requirements and state of the art standards. This staff‑level role serves as the software design assurance lead for complex, safety‑critical systems spanning embedded firmware, connected devices, mobile apps, and cloud services. You will embed with R&D as the quality core‑team representative to ensure design controls, risk management, cybersecurity, and verification/validation are planned and executed to deliver safe, effective Class III medical devices worldwide. You will operate within a global quality system aligned to FDA 21 CFR Part 820 (transitioning to QMSR aligned with ISO 13485), EU MDR 2017/745, ISO 13485:2016, ISO 14971:2019, and IEC 62304:2006+A1:2015.

What You’ll Work On 

• Own software design assurance for new products and significant changes across the full development life cycle; plan and lead design control activities, ensuring complete, auditable traceability from user needs through requirements, architecture, implementation, verification, validation, and release.

• As part of the Global Design Quality Department, provide oversight of R&D design control deliverables for development of medical product software (Cloud Patient Care Networks, mobile applications and embedded software), non-medical software, and non-product software

• Define and approve verification and validation strategies proportionate to software safety classification per IEC 62304; review and approve software development plans, requirements, test protocols and reports, cybersecurity tests, and associated documentation for embedded, mobile, and cloud components.

• Support software verification and validation activities for new products and software changes in accordance with plans.  Review and approve of requirements, software test case protocols/reports, software development plans, and other system and software documentation.

• Participate in meetings to evaluate, prioritize, and develop action plans for addressing software defects/bugs captured in the problem resolution systems

• Lead risk management for software and system hazards in accordance with ISO 14971, including risk management plans, hazard analyses, software FMEAs, fault trees as appropriate, benefit‑risk evaluations, risk controls, and production/post‑production feedback integration; ensure EU MDR expectations are met for software (including Rule 11 implications) and that EN ISO 14971 harmonization notes are applied where relevant. 

• Provide quality oversight for defect and change control processes, chair or co‑lead software defect triage as neede