Staff Engineer, Design Assurance- Software

Abbott • Pleasanton, CA

2d • Onsite

About The Position

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.

Requirements

• Bachelor’s degree, or equivalent experience, in a scientific, technical, or engineering discipline.
• Minimum 8 years of Software Development and Design Quality Engineering experience or an equivalent combination of education and experience.
• Knowledge of FDA regulations and guidance, ISO 13485, ISO 14971, Software Standards (e.g., 62304), EU Medical Device Regulations and MDSAP
• Experience with medical device software development lifecycle for Cloud-based networks and/or mobile applications.
• Demonstrated leadership as a quality core‑team member on complex programs involving mobile and cloud components; proficiency reviewing and approving requirements, architecture, verification/validation evidence, and risk files; fluency with defect and change control processes and audit practices seen at leading OEMs.

Nice To Haves

• Experience validating non‑product software and digital toolchains using FDA’s CSA approach, including cloud/SaaS platforms used in production and quality systems
• Strategic quality leadership that elevates design‑in quality and patient safety; the ability to influence design and product security strategy across disciplines; a mentoring mindset that grows software quality and risk management capabilities in the team; and calm, fact‑based execution during audits, escalations, and critical defect management. These are consistent with expectations for senior/staff software design assurance roles in top global device companies.
• Leadership experience coaching teams through design assurance gates for multi‑site, multi‑component systems; strong stakeholder management with R&D, Clinical, Regulatory, Security, Manufacturing, and Post‑Market Surveillance partners. Peer postings highlight this cross‑functional leadership as a differentiator for senior/staff roles
• Hands-on experience with FMEA/risk management.
• Experience developing or maintaining design controls for software development.

Responsibilities

• 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 needed, ensure risk‑based disposition of nonconformances and field issues, and lead or support CAPAs to effective closure with robust verification of effectiveness.
• Participate in technical and management reviews to ensure design plans, product designs, and deliverables related to product software are met.
• Represent the Global Design Quality Department for final review and approval of project deliverables
• Support non-product software validation by assessing the need for validation and preparing and/or supporting protocols, reports and other documentation as required.
• May be involved with supporting product cybersecurity assessments in conjunction with a cross-functional team.
• Mentor engineers in design controls, software life‑cycle best practices, cybersecurity by design, and risk management; influence design quality strategy and standard work across programs, helping the organization succeed through FDA’s QMSR transition while sustaining compliance to current QSR where applicable prior to the effective date.
• Prepare for and participate in internal and external audits and regulatory inspections; ensure Design History Files and EU Technical Documentation are complete, consistent, and inspection‑ready throughout development and transfer to manufacture.
• Comply with U.S. Food and Drug Administration (FDA) regulations, EUMDR, and other regulatory requirements and Abbott policies, processes, and procedures.

Benefits

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees