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 
•    This is not a remote opportunity 
•    Qualified candidates must currently live in the Irving, TX area.
•    Travel up to 10 %

What You’ll Work On
We are seeking an experienced professional to lead a team of Design Control Tools Subject Matter Experts (SMEs) and Level 1 Support staff. This team manages workflows for Design Inputs, Risk Management, Design Verification, Defect Management, and Validation data, primarily using OpenText Solutions Business Manager (SBM) and IBM Engineering Lifecycle Management (ELM). The role ensures quality compliance, configuration traceability, and release management across design control processes.

Key Responsibilities

Leadership & Strategy
•    Manage a team of SMEs and Level 1 Support staff focused on implementing policies and strategies for design control tools.
•    Develop and maintain a multi-year roadmap in collaboration with vendors to align internal deployment with market releases.
Technology & Innovation
•    Identify and evaluate emerging technologies (e.g., AI, Cloud) within the design control domain.
•    Stay current with industry trends and integrate innovative solutions into workflows.
Tool Development & Administration
•    Oversee design, development, and testing of design control tools.
•    Translate operating procedures into tool requirements for configuration and customization.
•    Formulate and implement business plans to enhance tool infrastructure and resolve technical challenges.
Support Management
•    Direct and mentor Level 1 Support staff to ensure timely resolution of user issues and effective escalation processes.
•    Establish and monitor service-level agreements (SLAs) for support activities.
Compliance & Risk Management
•    Lead projects ensuring adherence to quality procedures and risk mitigation strategies.
•    Coordinate with senior management to ensure timely project completion and interrelated design alignment.
Vendor & Contract Management
•    Negotiate licensing and service agreements with providers; collaborate with procurement to establish contracts.

Requirements Gathering
•    Identify system requirements for instruments, software, commodities, and assays through SME consultation, competitive analysis, and customer feedback.

Required Qualifications: 
•    Bachelor’s degree in computer science or related field OR 10+ years of equivalent experience with design control tools.
•    4+ years in FDA-regulated medical device or similar regulated industry managing requirements, risk, and/or test management data.
•    4+ years working with collaborative data management tools such as IBM DOORS, IBM ELM, OpenText SBM.

Preferred Qualifications: 
•    Experience managing technical support teams or service desk operations preferred.

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

$111,300.00 – $222,700.00

In specific locations, the pay range may vary from the range posted.

     

JOB FAMILY:

Product Development

     

DIVISION:

CRLB Core Lab

        

LOCATION:

United States > Irving : LC-02

     

ADDITIONAL LOCATIONS:

     

WORK SHIFT:

Standard

     

TRAVEL:

Yes, 10 % of the Time

     

MEDICAL SURVEILLANCE:

Not Applicable

     

SIGNIFICANT WORK ACTIVITIES:

Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day), Continuous standing for prolonged periods (more than 2 consecutive hours in an 8 hour day)

     

Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans.

     

EEO is the Law link - English: http://webstorage.abbott.com/common/External/EEO_English.pdf

     

EEO is the Law link - Espanol: http://webstorage.abbott.com/common/External/EEO_Spanish.pdf