Senior Risk Management Engineer (Medical Devices)

Abbott Laboratories; Saint Paul (MN); Presencial; USD 119.000 - 199.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Fast-paced environment

Tuition assistance

401(k) match

Health benefits

Paid time off

Training & development

Descripción de la vacante

Abbott Laboratories in Saint Paul, MN, seeks a Staff Risk Management Engineer II to assure product safety and quality, collaborating across clinical, design, regulatory and post-market teams. You will maintain risk management files, perform risk assessments, and drive improvements in risk controls and traceability.

The role requires strong domain knowledge in medical devices and regulatory frameworks. The position emphasizes risk analysis, process excellence, and collaboration within a

Formación

• 5+ years? experience in risk management or quality engineering.
• Experience in a medical device or regulated environment.
• Experience working in a broad enterprise/cross-division model.

Responsabilidades

• Ensure new products meet safety and quality requirements.
• Collaborate with clinical, design, regulatory, labeling and post-market teams.
• Maintain risk management documentation and traceability across hazards, risks and controls.
• Lead risk assessments (FMEAs/FTAs) and integrate cybersecurity risk with patient safety.

Conocimientos

Quality tools usage

Cross-functional collaboration

Risk assessment

Statistical methods

Educación

Bachelor's degree in Engineering or Technical Field

Herramientas

FMEA

FTA

ISO standards knowledge

Descripción del empleo

Abbott Laboratories in Saint Paul, MN, seeks a Staff Risk Management Engineer II to assure product safety and quality, collaborating across clinical, design, regulatory and post-market teams. You will maintain risk management files, perform risk assessments, and drive improvements in risk controls and traceability.

The role requires strong domain knowledge in medical devices and regulatory frameworks. The position emphasizes risk analysis, process excellence, and collaboration within a