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 114,000 colleagues serve people in more than 160 countries.

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 build the career you’ve dreamed of.Free medical coverage for employees who qualify under 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 the FreeU education benefit—an affordable and convenient path to earning 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 honored 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

This position is based in our Plymouth, MN location within the Electrophysiology Medical Device division. In Abbott’s Electrophysiology (EP) business, we’re advancing the treatment of heart disease through breakthrough medical technologies in atrial fibrillation—helping people restore their health and get on with their lives.

The Risk Management Engineer ensures new products perform their intended functions safely and comply with our quality system. This role collaborates with clinical, design engineering, regulatory, labeling, and post-market surveillance teams to ensure risks are appropriately mitigated, evaluated, disclosed, and monitored. The engineer maintains strong cross-functional partnerships to protect patient and user safety while meeting business needs.

What You’ll Work On

Product Development – Support/Execute Risk Management PlanSupport system/product risk management planningAssist in requirements development to ensure quality and linkage to the risk management fileSupport system hazard analysis and risk assessments (FTAs, FMEAs)Analyze and incorporate legacy inputs; coordinate cybersecurity risks with patient safety implicationsEnsure traceability among hazards, risks, analyses, evaluations, controls, and verification of control effectivenessContribute to system/product risk management reportsPost-Market SurveillanceServe as the point of contact for tracking and responding to post-market signals (event-based and periodic)Lead updates to the risk management file, including annual updatesConduct complaint analysis and develop action plansProvide backroom support for auditsRisk Management Tool MasteryDevelop proficiency in primary risk assessment tools (e.g., FMEA, FTA)Process ExcellenceIdentify and support improvements to risk management processes and infrastructureSupport changes driven by external regulations, standards, guidance, or internal Abbott Quality PoliciesAssist with CAPA efforts linked to risk management

Required Qualifications

Bachelor’s degree in Engineering or a technical field0-3 years of experiencePrevious design quality engineering experience and demonstrated use of quality tools/methodologiesExperience working in a cross-division or enterprise-wide business model

Preferred Qualifications

Advanced degreePrior medical device experienceExperience in a cross-division or enterprise-wide business modelWorking knowledge of FDA, GMP, and ISO 13485Familiarity with standards such as ISO 14971, IEC 60601, IEC 62304, IEC 62366, ISO 10993, and/or ISO 14155Systems or clinical engineering experienceExperience with basic statistics and/or reliability methodologiesExperience facilitating risk assessments (e.g., FMEAs or FTAs)

What We Offer

At Abbott, you can have a good job that grows into a great career. We offer:

A fast-paced work environment where your safety is a priorityClean, well-lit, and temperature-controlled production areasTraining and career development, including onboarding programs and tuition assistanceFinancial security through competitive compensation, incentives, and retirement plansHealth care and wellness programs including medical, dental, vision, and occupational healthPaid time off401(k) retirement savings with a generous company matchThe stability of a company with a strong financial track record and deep community involvement

Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives: www.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 www.abbott.com, on Facebook at facebook.com/Abbott, and on X @AbbottNews.

The base pay for this position is $50,000.00 – $100,000.00. In specific locations, the pay range may vary from the range posted.