Abbott
Healthcare
StaffEngineer,DesignAssurance-Software
Neural analysis suggests this role is
optimal for Staff candidates.
“Staff Engineer, Design Assurance- Software at Abbott. Skills: Software design assurance, Risk management, Design controls. Own software design assurance. Lead design control activities”
Industry & Context.
Root cause analysis; Problem resolution; Troubleshooting
10% travel
What They're Looking For.
Must Have
5+ years software design quality experience, Experience with FDA 21 CFR Part 820, Experience with ISO 13485:2016, Experience with ISO 14971:2019, Experience with IEC 62304:2006+A1:2015, Experience with EU MDR 2017/745
Nice to Have
Experience validating non-product software, Experience with cloud/SaaS platforms, Leadership experience coaching teams, Hands-on FMEA/risk management experience, Experience developing design controls
What You'll Do.
Own software design assurance
Lead design control activities
Provide oversight of R&D design control
Define verification and validation strategies
Approve software development plans
Approve test protocols
Approve cybersecurity tests
Support software verification activities
Support software validation activities
Participate in meetings to evaluate defects
Develop action plans for defects
Lead risk management for hazards
Ensure EU MDR expectations are met
Provide quality oversight for defect control
Provide quality oversight for change control
Chair software defect triage
Lead CAPAs to closure
Verify CAPA effectiveness
Participate in technical reviews
Participate in management reviews
Represent Global Design Quality Department
Approve project deliverables
Support non-product software validation
Assess need for validation
Prepare validation protocols
Support validation reports
Support product cybersecurity assessments
Mentor engineers in design controls
Mentor engineers in software lifecycle
Mentor engineers in cybersecurity
Influence design quality strategy
Influence standard work
Prepare for internal audits
Participate in internal audits
Prepare for external audits
Participate in external audits
Ensure Design History Files are complete
Ensure EU Technical Documentation are complete
How You'll Work.
Team & Collaboration
Cross-functional team; R&D; Clinical; Regulatory; Security; Manufacturing; Post-Market Surveillance
Communication Scope
Technical documentation
Process & Methodology
Design controls, Software development plans
Full Job Description
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 115,000 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](https://www.abbott.com/corpnewsroom/strategy-and-strength/tackling-student-debt-for-our-employees.html) student debt program and [FreeU](https://www.abbott.com/corpnewsroom/strategy-and-strength/college-degree-for-free-its-possible-with-freeu.html) 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 d
Applying for this Staff Engineer, Design Assurance- Software role?
Most applicants get filtered before a human reads their resume. See if yours makes the cut.
How to Apply on Workday
- Workday has a multi-step form — save your progress after every section.
- "Apply With LinkedIn" can fail or lose data; manual entry is more reliable.
- Watch for the "Submit for Review" final step — hitting "Save" alone does not submit.
- Job requisition numbers are useful when following up with HR by email.
ANONYMOUS · UNFILTERED
What do employees actually say about Abbott?
Real rants from real employees. Read before you apply.