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 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 – $120,000.00In specific locations, the pay range may vary from the range posted.
Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans.
EEO is the Law link - English: http://webstorage.abbott.com/common/External/EEO_English.pdf
EEO is the Law link - Espanol: http://webstorage.abbott.com/common/External/EEO_Spanish.pdf