Scientist Operations II

Abbott • Chicago, IL

1d • $68,000 - $136,000 • Onsite

About The Position

The Scientist Operations II works out of the Abbott Park location in the Abbott Diagnostics Division. 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. The person hired is an individual contributor that works under limited supervision. Applies subject matter knowledge; requires capacity to understand specific needs or requirements to apply skills/knowledge. Carries out fundamental or applied research in the biological or physical sciences or in mathematics requiring appreciable originality and ingenuity. Applies subject matter knowledge and skills in an applied research area of their specialization. Roles require a basic understanding of a number of disciplines. Positions may involve the introduction and application of new developments in their field and may also require the development of new approaches to be used by other professions. Support development of reports to direct recommendations and conclusions and evaluate findings. Provides information essential to estimate the costs, resources, and time required to implement the organization’s annual R&D goals and monitor the performance of research projects to ensure targets are met. May liaise with the external scientific community.

Requirements

• Associates Degree and Minimum 1 year of work experience.
• Working knowledge of regulatory requirements (e.g., FDA, IVDR) and their application to product changes and lifecycle management.
• Experience evaluating change impact across cross-functional areas (Regulatory Affairs, Risk Management, Product, Quality, Manufacturing) while collaborating with R&D, Supply Chain, and other teams to drive alignment and implementation.
• Familiarity with risk assessment methodologies, including identifying, evaluating, and documenting risks associated with product or process changes.
• Experience maintaining compliance with design control and change control procedures within a regulated environment.
• Excellent organizational and communication skills, with the ability to summarize complex change impacts and present recommendations clearly to stakeholders.

Nice To Haves

• Minimum of 3 years of experience in change control, change management, or related quality/regulatory processes within a regulated industry (medical device/diagnostics)
• Demonstrated experience supporting change management processes for medical devices or diagnostic products, including assessment of design, process, or material changes.
• Proficiency in tools and systems used for document control, product lifecycle management (PLM), or quality management systems (QMS).
• Experience supporting global regulatory submissions or notifications related to product changes.

Responsibilities

• Carries out fundamental or applied research in the biological or physical sciences or in mathematics requiring appreciable originality and ingenuity.
• Applies subject matter knowledge and skills in an applied research area of their specialization.
• Support development of reports to direct recommendations and conclusions and evaluate findings.
• Provides information essential to estimate the costs, resources, and time required to implement the organization’s annual R&D goals and monitor the performance of research projects to ensure targets are met.
• May liaise with the external scientific community.
• Own and manage end-to-end coordination of change controls (e.g., design, process, supplier, labeling changes)
• Serve as the primary coordinator between CFT functions
• Ability to coordinate and track change control activities (e.g., design change requests) ensuring thorough documentation and timely execution.

Benefits

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: Associate degree