Staff Systems Integration Specialist

Abbott Laboratories; Northern (KY); On-site; USD 110,000 - 170,000; Full time

Job summary

Abbott is seeking a Staff Systems Integration Specialist for our Diagnostics/Core Lab. The role is based on-site at Abbott Park, IL, focusing on integrating subsystems and ensuring system performance across hardware, software, assays, and labeling.

You will lead risk assessments, develop test methods, mentor engineers, and drive data-driven improvements aligned with quality and regulatory requirements.

Qualifications

• Bachelor’s degree in Life or Physical Science, Bioengineering, Biomedical Engineering, or closely related discipline.
• Minimum 7 years recognized experience leading complex system and risk analysis.
• Demonstrated ability to lead and influence stakeholders using data to make decisions.

Responsibilities

• Ensure and verify the design of subsystems to function as a system.
• Define and document system requirements across hardware, software, assays, reagents, and labeling.
• Develop and execute integration, verification, and validation testing.
• Analyze data, interpret results, and recommend improvements to product performance.
• Lead risk management activities including FMEA and hazard assessments.
• Mentor team members and collaborate across engineering, quality, and operations.
• Drive data-based decision-making using statistics and DOE.

Skills

Lead complex system analysis

Risk analysis

Data-driven decisions

Systems thinking

Regulatory/compliance awareness

Mentor and collaboration

Education

Bachelor’s degree in Life or Physical Science, Bioengineering or Biomedical Engineering

Tools

DOORS

APLM

SBM

Job description

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 115,000 colleagues serve people in more than 160 countries.

Descritivo de Cargo

Working at Abbott At Abbott, you can do work that matters, grow, learn, care for yourself and your 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 a 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 worldwide 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 the best place to work for diversity, working mothers, female executives, and scientists.

The Opportunity

Our Diagnostics / Core Lab business currently has a full-time, on‑site opportunity for a Staff Systems Integration Specialist. This position will be based at our Abbott Park, IL office. Our diagnostic solutions are used in hospitals, laboratories, and clinics around the globe. The crucial information derived from our tests, instruments, and informatics systems is 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.

What You’ll Work On

The Staff Systems Integration Specialist applies an interdisciplinary, collaborative approach to ensure and verify the design of the subsystems integrate and function optimally as a system, to provide system solutions, improvements, and enhancements to achieve overall systems performance. Resolves product problems and technical issues with minimal oversight across multiple system functions. In addition: Ensure compliance with quality and regulatory requirements while supporting continuous improvement efforts. Define and document system requirements across hardware, software, assays, reagents, and labeling to ensure products perform as intended. Develop and execute integration, verification, and validation testing to assess overall system performance and reliability. Analyze technical data, interpret results, and recommend improvements to product performance, quality, and manufacturing processes. Create, review, and maintain assay files, ensuring accuracy and compliance for new product launches and product changes. Support risk management activities, including FMEA reviews, hazard assessments, and performance optimization studies. Document testing, investigations, and engineering activities to meet quality system and design control requirements. Mentor team members, share technical expertise, and collaborate across engineering, scientific, quality, and operations teams. Manage multiple projects, maintain organized records, and consistently meet project timelines. Drive data‑based decision‑making using statistical analysis, experimental design, and performance metrics. Leads development of systems integration test methods / processes and troubleshooting instrument (hardware/software/and assay/reagent interaction issues to determine root cause and possible solutions. Resolves complex system‑level problems. Leads team members in application and analysis of multiple optimization process techniques: Set targets, ranges, and specs – DOE, Guard band, Capability (CPk), Test Method development, troubleshoot parts and subsystems. Reviews and / or develop FMEA, hazards, modes of control for risk management. Leads complex investigations involving interacting system level issues. Responsible for implementing and maintaining the effectiveness of the quality system. Proficiency in assay file parameters review and the assay file management system.

Required Qualifications

Bachelor’s degree in Life or Physical Science, Bioengineering, Biomedical Engineering, or closely related discipline is preferred. Minimum 7 years Recognized experience leading complex system and risk analysis Demonstrated ability to lead and utilize data to make decisions and influence stakeholders Demonstrated success in technical proficiency, creativity, and independent thought. Demonstrated ability to apply principles of systems thinking to accelerate performance Expert knowledge of systems and/or assay development principles and concepts Knowledge of Product Risk Management Best Practices and Tools Demonstrated Customer Focus, making their needs a primary focus of one’s actions.

Preferred Qualifications

Systems integration experience in Clinical Chemistry and / or Immuno Assay Experience in Clinical Chemistry, immunoassay development, assay technical support or assay reagent design. Demonstrated Customer Focus, making their needs a primary focus of one’s actions. Knowledge of regulations and standards affecting IVDs and Biologics. Demonstrates use of statistics, design of experimentation, DOORS, APLM, SBM and Comfortable working with technical data, test methods, and regulated product development processes. Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives: https://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 abbott.com, on LinkedIn at https://www.linkedin.com/company/abbott-/, and on Facebook at https://www.facebook.com/AbbottCareers.

Familia de Cargo

Product Development Divisão CRLB Core Lab Localidade United States > Abbott Park : AP20 Localidades Adicionais Turno de Trabalho Standard Viagem Yes, 5 % of the Time Vigilância médica No Atividades de trabalho significativas Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day), Keyboard use (greater or equal to 50% of the workday) Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans. EEE is the Law link - English: http://webstorage.abbott.com/common/External/EEO_English.pdf EEE is the Law link - Espanol: http://webstorage.abbott.com/common/External/EEO_Spanish.pdf A Abbott significa o poder da saúde. Por mais de 125 anos, a Abbott tem ajudado as pessoas a alcançar seu potencial — porque uma saúde melhor permite que indivíduos e comunidades vivam melhor. Com uma rede global e diversificada, que serve clientes em mais de 160 países, criamos novas soluções — em todo o espectro da saúde, em todo o mundo, para todas as fases da vida. Seja através da próxima geração de equipamentos de diagnóstico, dispositivos médicos para estilos de vida em transformação, nutrição baseada em ciência, ou novas reformulações, estamos desenvolvendo tecnologias mais inovadoras e revolucionárias na área da saúde para que indivíduos vivam melhor e com mais saúde. Os colaboradores da Abbott vêm trabalhar todos os dias com energia, entusiasmo e comprometimento com o intuito de promover a saúde e o bem-estar de milhões de pessoas. Eles superam os limites para ajudar a gerenciar e tratar alguns dos maiores desafios de saúde da vida. Convidamos você a explorar as oportunidades na Abbott, a ver se seus talentos e aspirações de carreira podem se encaixar com as nossas vagas. A Abbott é uma empresa que oferece oportunidades iguais e acolhe e incentiva a diversidade em nossa força de trabalho. Siga-nos: Facebook LinkedIn YouTube Twitter