Staff Systems Integration Specialist

About the role

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.

• 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.