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.

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 will have access to:

Career development with an international company where you can grow the career you dream of.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.

The Opportunity

This position works out of our [insert location of working site] location in the [insert division name. [Insert division description]. 

As the Sr. Risk Management Engineer, you’ll assure new or modified products and processes perform the functions intended in a safe manner and establishes compliance with the Quality System. They collaborate with clinical, design engineering, quality engineering, regulatory, labeling, and post market surveillance functions to ensure that risk is appropriately mitigated, evaluated, disclosed, and monitored. They are responsible for maintaining a strong collaborative partnership with cross-functional team members that facilitates organizational success by protecting patient/user safety and meeting business needs.

What You’ll Do

Execute and own and guide others on-time completion of Risk Management Deliverables. Ability to work with highly complex or specialized projects.Maintain Risk Management deliverables to ensure continued acceptability of product based on post market feedbackSupport Product Performance Group Risk Escalation process and understanding of complaint handling processCAPA ownershipOwn Notified / Regulatory body inquiries.Own on-time execution of Quality Plans for internal development, OEM-based, Clinical Product Development, and design change projects.Support Risk Management activities from product Concept through product obsolescence.Support DHF content completion, integrity, and regulatory & standards compliance; collaboratively communicating & resolving gaps.Drive creation of risk mitigation strategy and support the establishment of objective, measurable, discrete, and verifiable customer and product requirements to meet that strategy.Ensure verification and validation evidence supports the planned risk mitigation strategy.Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments. Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.

Shift: Admin

Required Qualifications

Bachelor´s degree in STEM Careers, Advance or master’s degree preferred5+ years’ experience in Quality engineering with at least 3 years’ experience executing risk management deliverables.Advance command of English. Fluent oral and writing communication including technical writing.Working knowledge and expertise of EUMDR and FDA requirementsExtensive experience in risk management, including a working knowledge of ISO 14971 and 62366, and TR 24971.Knowledge of field monitoring processes  In Depth understanding of how design controls interact with risk management.

Preferred Qualifications

Previous quality engineering experience and demonstrated use of quality tools/methodologiesSolid verbal, written, and interpersonal skills with ability to effectively communicate at multiple levels in the organization.Experience working in a broader enterprise/cross-division business unit model preferred.Ability to work in a matrixed and geographically diverse business environment.Ability to work within a team and as an individual contributor in a fast-paced, changing environment. Ability to leverage and/or engage others to accomplish projects.  Multitasks, prioritizes and meets deadlines in timely manner.  Strong organizational and follow-up skills, as well as attention to detail. Systems or clinical engineering experience  Experience with basic statistics and/or reliability methodologiesWorking knowledge of how design controls interact with risk management7+ years’ experience preferred Note: This job description is not to be considered an exhaustive statement of duties, responsibilities.

Apply Now

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.

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