Staff Medical Device Risk Management Engineer

Abbott Laboratories; Saint Paul (MN); On-site; USD 120,000 - 160,000; Full time

Job summary

Abbott Laboratories seeks a Staff Risk Management Engineer to lead risk management activities for innovative medical products. You will own risk files across the product lifecycle, performing hazard analyses, FMEA/FMECA, and fault tree analysis to ensure patient safety and regulatory compliance (ISO 14971, FDA, EU MDR).

Partner with R&D, Quality, Regulatory, and Manufacturing to define risk controls, assess residual risk, and support design reviews, V&V, and post-market surveillance.

Qualifications

• Knowledge of ISO 14971 risk management framework and regulatory expectations (FDA, EU MDR) is preferred.

Responsibilities

• Lead risk management activities across the product lifecycle.
• Perform hazard analyses, FMEA/FMECA, and fault tree analysis to ensure patient safety and regulatory compliance.

Job description

Abbott Laboratories seeks a Staff Risk Management Engineer to lead risk management activities for innovative medical products. You will own risk files across the product lifecycle, performing hazard analyses, FMEA/FMECA, and fault tree analysis to ensure patient safety and regulatory compliance (ISO 14971, FDA, EU MDR). Partner with R&D, Quality, Regulatory, and Manufacturing to define risk controls, assess residual risk, and support design reviews, V&V, and post-market surveillance. Mentor teams in risk processes, drive continuous improvement in quality systems, and contribute to global, life-changing healthcare solutions in a collaborative, inclusive environment.