Risk Management Engineer II

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.

     

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 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 Staff 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 Plan

  • Support system/product risk management planning

  • Assist in requirements development to ensure quality and linkage to the risk management file

  • Support system hazard analysis and risk assessments (FTAs, FMEAs)

  • Analyze and incorporate legacy inputs; coordinate cybersecurity risks with patient safety implications

  • Ensure traceability among hazards, risks, analyses, evaluations, controls, and verification of control effectiveness

  • Contribute to system/product risk management reports

• Post-Market Surveillance

  • Serve 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 updates

  • Conduct complaint analysis and develop action plans

  • Provide backroom support for audits

• Risk Management Tool Mastery

  • Develop proficiency in primary risk assessment tools (e.g., FMEA, FTA)

• Process Excellence

  • Identify and support improvements to risk management processes and infrastructure

  • Support changes driven by external regulations, standards, guidance, or internal Abbott Quality Policies

  • Assist with CAPA efforts linked to risk management

Required Qualifications

• Bachelor’s degree in Engineering or a technical field

• 3+ years of experience

• Previous design quality engineering experience and demonstrated use of quality tools/methodologies

• Experience working in a cross-division or enterprise-wide business model

Preferred Qualifications

• Advanced degree

• Prior medical device experience

• Experience in a cross-division or enterprise-wide business model

• Working knowledge of FDA, GMP, and ISO 13485

• Familiarity with standards such as ISO 14971, IEC 60601, IEC 62304, IEC 623