Scientist Operations II at Abbott in Abbott Park, IL

SCIENTIST OPERATIONS II Location: United States - Illinois - Abbott Park 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. JOB DESCRIPTION: Working at Abbott At Abbott, you can do work that matters, grow, and 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 The Scientist Operations II, works out of our Abbott Park location in 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.  What You’ll Work On 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.   Required Qualifications • Associates Degree and Minimum 1 year of work experience. Preferred Qualifications: • 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. • Own and manage end-to-end coordination of change controls (e.g., design, process, supplier, labeling changes) • 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.  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. • 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. • Proficiency in tools and systems used for document control, product lifecycle management (PLM), or quality management systems (QMS). • Excellent organizational and communication skills, with the ability to summarize complex change impacts and present recommendations clearly to stakeholders. • Experience supporting global regulatory submissions or notifications related to product changes. 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. The base pay for this position is $68,000.00 – $136,000.00 In specific locations, the pay range may vary from the range posted. JOB FAMILY: Research and Discovery DIVISION: CRLB Core Lab LOCATION: United States > Abbott Park : AP01A ADDITIONAL LOCATIONS: WORK SHIFT: Standard TRAVEL: Yes, 5 % of the Time MEDICAL SURVEILLANCE: No 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), Keyboard use (greater or equal to 50% of the workday) 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