Senior Compliance Software Engineer (Product)

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:

Senior Compliance Software Engineer (Product)

 

Working at Abbott

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.
• Free medical coverage for employees* via the Health Investment Plan (HIP) PPO
• 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

The Senior Compliance Software Engineer (Product) will be responsible (but not limited to) the following:

• Participates as a lead member of the Software Quality Assurance (SWQA) team for Abbott Diabetes Care products that ensures digital applications and firmware produced by ADC is developed, validated, and maintained in compliance with regulatory, corporate and divisional requirements.
• Review quality system documentation products as they apply to the development, verification, validation, use, and maintenance of medical device software.
• Coordinate activities with other engineering disciplines, departments, and contractors.

What You'll Work On

• Completes software quality tasks in accordance with current Quality System Requirements.
• Works independently with objectives given by SWQA Manager.
• Can plan and coordinate own work according to higher-level project schedules.
• Reviews and provides lead guidance to the team regarding deliverables/activities as identified in project plans or equivalent documentation. Including System Specifications/Requirements documents, Verification Test Cases, Verification/Validation protocols, Trace Matrices and Verification/Validation Summary Reports for the Alameda site.
• Reports unexpected events, issues or software bugs which occur during verification/validation to project team and management. Assists subordinate staff in recognizing the same.
• Coordinates the development and maintenance of departmental operating procedures to ensure compliance to relevant FDA, QSR, ISO guidelines, including 21 CFR Part 11 and Abbott Corporate requirements as they relate to the development, verification, validation, and maintenance of application in support of medical device software.
• Software Quality lead in various phases of the development lifecycle, as well as initiation of corrective and/or preventative action as it applies software development activities.
• Maintains schedule and drive to meet project schedule as aligned with project(s) goals.
• Will also estimate, plan, schedule and review own and others’ work products and be accountable for the quality of those reviews and delivery on schedule.
• Considered Non-Product SWQA compliance SME in support of external/internal audits.

Required Qualifications

• Bachelor’s degree, or equivalent experience, in a scientific, technical, or engineering discipline. 
• 5 to 8 years’ experience in Software Quality Assurance and/or Software Testing experience. 
• Knowledge of FDA QSR, relevant ISO guidelines and 21 CFR Part 11. Has knowledge of Design Control requirements.
• Must have 2 - 4 years project experience in software testing practices, methodologies including Agile and techniques, preferably in testing medical devices.
• Must have excellent oral and written communication skills.

Preferred Qualifications:

• ASQ Certifications a plus.
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