Abbott

Healthcare

StaffEngineer,DesignAssurance-Software

$114–228k Pleasanton, California, United States; Burlington, Massachusetts, United States; Atlanta, Georgia, United States FULL TIME
Market Sentiment
HIGH DEMAND

Neural analysis suggests this role is
optimal for Staff candidates.

The Brief

“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.

Healthcare
Problems you'll solve

Root cause analysis; Problem resolution; Troubleshooting

Eligibility Requirements

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

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