Staff Engineer, Design Assurance- Software – Abbott – Jobs in Pleasanton, CA | OpenJobs AI

Job Details

Overview Company

Staff Engineer, Design Assurance- Software

$114k/y-$228k/y

Abbott

a day ago

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OnsiteFull-timeSenior

Summary

Abbott is seeking a Staff Engineer, Design Assurance- Software to join their team in Pleasanton, CA. The role involves ensuring medical devices are developed in accordance with Abbott's design control requirements and state of the art standards.

About the Role

As a Staff Engineer, Software Design Quality, you will serve as the software design assurance lead for complex, safety-critical systems spanning embedded firmware, connected devices, mobile apps, and cloud services. You will be responsible for planning and leading design control activities, ensuring traceability from user needs through requirements, architecture, implementation, verification, validation, and release. You will also provide oversight of R&D design control deliverables, define verification and validation strategies, support software verification and validation activities, and mentor engineers in design controls and risk management.

About You

Required:

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.

Preferred:

Experience validating non-product software and digital toolchains using FDA's CSA approach.
Strategic quality leadership that elevates design-in quality and patient safety.
Leadership experience coaching teams through design assurance gates for multi-site, multi-component systems.
Hands-on experience with FMEA/risk management.
Experience developing or maintaining design controls for software development.

Benefits

Career development with an international company.
Free medical coverage in the Health Investment Plan (HIP) PPO medical plan.
Excellent retirement savings plan with high employer contribution.
Tuition reimbursement and FreeU education benefit.
Recognition as a great place to work in multiple countries.

Abbott

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, nutritional and branded generic medicines. Our 114,000 colleagues serve people in more than 160 countries. Connect with us at www.abbott.com, on Facebook at www.facebook.com/Abbott and www.facebook.com/AbbottCareers, on Instagram @AbbottGlobal, and on X @AbbottNews. We invite you to explore opportunities at Abbott, to see if your talents and career aspirations may fit with our openings. An equal opportunity employer, Abbott welcomes and encourages diversity in our workforce. Terms of Use: https://www.abbott.com/social-media-terms-of-use.htm

Pleasanton, CA