Principal Design Quality Engineer, Risk Management

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:

About Abbott

Abbott is a global healthcare leader, creating breakthrough science to improve people’s health. We’re always looking towards the future, anticipating changes in medical science and technology.

Our diagnostic solutions are used in hospitals, laboratories, and clinics around the globe. The crucial information derived from our tests, instruments and informatics systems are often the first step in patient care decision making for hundreds of health conditions from heart attacks to blood disorders to infectious diseases and cancers.

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.
• 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

Our location in Irving, TX has an open opportunity for a Principal Design Quality Engineer, Risk Management. This person will be responsible to review and participate in all aspects of product risk characterization, prioritization and management for On-Market and New Product Development activity.  It is expected to have a firm understanding of risk management best practices & tools comprehending the identification, analysis, mitigation, tracking and controlling of risks as applied to hardware and software product development.  Effective navigation & facilitation of these processes and procedures is paramount to ensuring product teams deliver safe and effective products.

Secondary function is to review and participate in all aspects of product design control for On-Market and In-Development activity in the Medical Device space.  It is expected to have a firm understanding of the design input, risk management, design verification, design validation and design output/transfer processes & tools as applied to product development.  Effective navigation & facilitation of these processes and procedures is paramount to ensuring product teams deliver safe and effective products.

What You’ll Work On

Responsible for implementing and maintaining the effectiveness of the quality system.

• Risk Management - Understands and applies basic Risk Management principles.

  Maintains the risk management process including Risk Identification, Risk Analysis, Risk Mitigation, Risk Monitoring and Risk Reduction

  Coordinates across functional teams in the development & execution of design risk analyses for Design Plans, Design Reviews, Design Change Requests and d/p/u FMEAs

  Performs risk assessments for Defect Tracking Support, Technical Review Boards & CAPAs

  Participates on the Risk Management Team and establishes system risk documentation including the Risk Management Plan, Risk Management Report, Post Market Risk Evaluation, Fault Tree Analysis, etc.

• Design Verification/Validation – Understands and applies basic Design Verification/Validation methods & principles.  Participates in the development, modification and design review of Protocols, Data Summaries & Records.  Provides guidance on developing and implementing test strategies & methodologies.
• Complaint/Defect Evaluation - Investigates complex complaints and/or defects with management oversight. Provides compliant solutions to a variety of complex problems. Ensures compliant documentation related to area of responsibility