Risk Management Engineer II

Abbott Laboratories • Saint Paul, MN

101d • $60,000 - $120,000

About The Position

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.

Requirements

• 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

Nice To Haves

• 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)

Responsibilities

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

Benefits

• 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
• The FreeU education benefit—an affordable and convenient path to earning a bachelor's degree
• 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

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Industry: Computer and Electronic Product Manufacturing
• Education Level: Bachelor's degree