Software Engineer

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.

Our location in Abbott Park, IL currently has an opportunity for a Software Engineer.

What You’ll Do

• Configure and customize LIMS (Laboratory Information Management System) software to align with laboratory workflows, regulatory requirements, and business objectives.
• Develop and maintain interfaces between laboratory instruments and the LIMS to ensure seamless data integration and traceability.
• Troubleshoot and resolve LIMS-related issues, following established change control and incident management processes.
• Collaborate cross-functionally with laboratory personnel, IT, software quality assurance (SQA), and regulatory teams to ensure system effectiveness and compliance.
• Support software validation activities, including the creation and execution of validation deliverables such as risk assessments (e.g., FMEAs), validation plans, requirements, test protocols, and traceability matrices.
• Ensure compliance with applicable regulations and standards, including FDA 21 CFR Part 11, ISO 13485, and internal corporate quality policies.
• Participate in audits and inspections, providing documentation and subject matter expertise related to LIMS and computerized systems.
• Apply risk management principles to identify, assess, and mitigate risks associated with system changes and non-conformances.
• Identify opportunities for process improvement and contribute to continuous improvement initiatives within the laboratory informatics space.
• Provide end-user training and support, ensuring proper system usage and documentation practices.

Education and Experience

Required

• Bachelor’s degree in computer science, Software Engineering, or a closely related discipline.
• Minimum of 4 years of related work experience in LIMS, software development, or laboratory informatics.
• Strong knowledge of FDA regulations, Quality System Regulations (QSR), Medical Device Directive, ISO guidelines, and 21 CFR Part 11.
• Proficiency in scripting languages such as JavaScript and VBScript, as well as SQL and HTML5.
• Familiarity with regulatory compliance in laboratory environments.
• Experience with system integration and data migration is a plus.

Preferred

• Experience with STARLIMS v12 or higher.
• Knowledge of laboratory processes in pharmaceutical, biotech, or healthcare environments.
• Understanding of software development lifecycle (SDLC) and Agile methodologies.

The base pay for this position is $75,300.00 – $150,700.00. In specific locations, the pay range may vary from the range posted.

Qualifications

• Bachelor’s degree in computer science, Software Engineering, or a closely related discipline
• Minimum of 4 years of related work experience in LIMS, software development, or laboratory informatics
• Strong knowledge of FDA regulations, Quality System Regulations (QSR), Medical Device Directive, ISO guidelines, and 21 CFR Part 11
• Proficiency in scripting languages such as JavaScript and VBScript, as well as SQL and HTML5
• Familiarity with regulatory compliance in laboratory environments

Benefits

• 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
• 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
• The base pay for this position is $75,300.00 – $150,700.00
• In specific locations, the pay range may vary from the range posted

Responsibilities

• Configure and customize LIMS (Laboratory Information Management System) software to align with laboratory workflows, regulatory requirements, and business objectives
• Develop and maintain interfaces between laboratory instruments and the LIMS to ensure seamless data integration and traceability
• Troubleshoot and resolve LIMS-related issues, following established change control and incident management processes
• Collaborate cross-functionally with laboratory personnel, IT, software quality assurance (SQA), and regulatory teams to ensure system effectiveness and compliance
• Support software validation activities, including the creation and execution of validation deliverables such as risk assessments (e.g., FMEAs), validation plans, requirements, test protocols, and traceability matrices
• Ensure compliance with applicable regulations and standards, including FDA 21 CFR Part 11, ISO 13485, and internal corporate quality policies
• Participate in audits and inspections, providing documentation and subject matter expertise related to LIMS and computerized systems
• Apply risk management principles to identify, assess, and mitigate risks associated with system changes and non-conformances
• Identify opportunities for process improvement and contribute to continuous improvement initiatives within the laboratory informatics space
• Provide end-user training and support, ensuring proper system usage and documentation practices