Principal Design Quality Engineer, Risk Management

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.
• Documentation - Reviews documentation for accuracy, clarity, consistency, completeness and compliance for projects that vary from low to high complexity. Plans and performs assignments with a wide degree of difficulty.
• Quality System Compliance -Maintains awareness of standards that regulate our industry. Ensures compliance to site level policies and procedures by promptly reporting non-compliance issues to management within Division and Corporation as appropriate. Maintains vigilance to ensure adherence to Quality Policy and Quality system procedures by promptly reporting noncompliance issues to management.
• Quality Engineering – Participates on project teams and technical review boards.  Coordinates quality decisions between different quality and engineering groups.  Effectively navigates & facilitates project teams with respect to our processes and procedures ensuring the delivery of safe and effective products.

Accountability/Scope: 

Strong leadership skills, including the ability to set goals and provide positive and constructive feedback respectfully to build positive relationships and improve business results. Ability to work effectively within a team in a dynamic & fast-paced environment. Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization. Multi-tasks, prioritizes and meets deadlines in timely manner. Strong organizational, planning, and follow-up skills and ability to hold others accountable. Comprehends the implications & consequences of how proposed changes and project demands will affect both internal & external customers.

Required Qualifications

• B.S. in Systems Engineering; Biomedical Engineering; Life Science or closely related discipline is required or relevant combination of education & experience.
• Minimum 7+ years’ experience covering the entire design control/risk management process in a team-oriented environment.
• Strong Knowledgeable of FDA, Quality System Regulations (QSR), Medical Device Directive, ISO guidelines, ISO 14971 Risk Management and 21 CFR Part 11.
• Project experience in hardware and software risk practices, methodologies and techniques, particularly associated with medical devices

Preferred Qualifications

• Master’s Degree is a plus.
• Experience with Serena Business Manager, Siemens Teamcenter Product Data Management & IBM DOORS.

Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives:  www.abbottbenefits.com

Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer, committed to employee diversity.

Connect with us at www.abbott.com, on Facebook at www.facebook.com/Abbott and on Twitter @AbbottNews and @AbbottGlobal.

The base pay for this position is $97,300.00 – $194,700.00. In specific locations, the pay range may vary from the range posted.

• risk management
• design control
• quality system compliance
• design verification
• design validation
• fda regulations
• iso guidelines
• risk assessment
• technical review
• complaint evaluation
• documentation review
• project management
• team collaboration
• communication skills
• problem solving
• organizational skills
• leadership skills
• planning skills