Risk Management Engineer II

Job description

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 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 62366, ISO 10993, and/or ISO 14155
+ Systems or clinical engineering experience
+ Experience with basic statistics and/or reliability methodologies
+ Experience 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 priority
+ Clean, well-lit, and temperature-controlled production areas
+ Training and career development, including onboarding programs and tuition assistance
+ Financial security through competitive compensation, incentives, and retirement plans
+ Health care and wellness programs including medical, dental, vision, and occupational health
+ Paid time off
+ 401(k) retirement savings with a generous company match
+ The 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 $60,000.00 – $120,000.00.

In specific locations, the pay range may vary from the range posted.

An Equal Opportunity Employer
Abbot welcomes and encourages diversity in our workforce.
We provide reasonable accommodation to qualified individuals with disabilities.
To request accommodation, please call 224-667-4913 or email corpjat@abbott.com

Required Skill Profession

Other General