Risk Management Engineer II

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.

Structural Heart

Structural Heart Business Mission: Why We Exist

Our business purpose is to restore health and improve quality of life by designing and providing device and management solutions for treating structural heart disease.

A Risk Management Engineer II assures new or modified products perform the functions intended in a safe manner and establishes compliance with the quality system.  They collaborate with Clinical Engineering, Research & Development, Regulatory Affairs, 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. They act as the liaison between the Risk Management and Post-Market Surveillance teams to ensure customer feedback data is arranged to facilitate efficient adjudication of the data. They own projects for improving the Risk Management process.

This position will be at our Woodridge location in Minnesota.

• →Support Risk Management activities from product concept through product obsolescence.
• →Support creation of risk mitigation strategy and establishment of objective, measurable, discrete, and verifiable customer and product requirements to meet that strategy
• →Create and update Risk Management Plans, Hazard Analyses, c/d/p/uFMEAs, and Risk Management Reports
• →Ensure verification and validation evidence supports the planned risk mitigation strategy
• →Maintain Risk Management File to ensure continued acceptability of product based on post market feedback
• →Support CAPAs
• →Support Notified / Regulatory Body inquiries
• →Own risk management process improvement projects
• →Complete Document Change Request Reviews in a timely and objective manner
• →Additional duties may be identified by functional management based on the current project/business objectives, including up to 10% travel.

• Bachelor’s degree in Biomedical Engineering, Mechanical Engineering or other technical fields
• 3-5 years’ experience in Medical Devices, preferably with Class III implantable cardiovascular products
• Previous Quality Engineering, Risk Management experience
• Working knowledge of ISO 14971 and ISO 13485 standards
• Solid verbal, written, and interpersonal skills with ability to effectively communicate at multiple levels in the organization
• Ability to work within a team and as an individual contributor in a fast-paced, changing environment.
• Ability to work in a matrixed and geographically diverse business environment.
• Multitasks, prioritizes and meets deadlines in timely manner.
• Strong organizational and follow-up skills, as well as attention to detail.

• Knowledge of Complaint Handling process
• Working knowledge of EUMDR requirements
• Experience with basic statistics
• Clinical engineering experience

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