Senior Risk Management Engineer – Medical Devices

Thornton Tomasetti; Saint Paul (MN); On-site; USD 99,000 - 199,000; Full time

Benefits offered by this job

Tuition reimbursement

Health care programs

401(k) retirement savings with company

Paid time off

Job summary

Abbott's Electrophysiology (EP) business in Saint Paul, MN is seeking a Staff Risk Management Engineer II to assure new products perform safely and meet quality requirements. You will partner with clinical, design, regulatory, and post-market teams to mitigate risk and safeguard patient safety while enabling business goals.

In this role you will develop risk management plans, support hazard analyses and risk assessments (FMEA/FTA), maintain traceability, and drive risk file updates.

Qualifications

• Bachelor level degree in Engineering or Technical Field.
• 5+ years’ experience.
• Previous design quality engineering experience and demonstrated use of quality tools/methodologies.
• Experience working in a broader enterprise/cross‑division business unit model.
• FDA, GMP, ISO 13485 knowledge preferred.

Responsibilities

• Develop and execute risk management plans for products.
• Coordinate risk management with clinical, regulatory, and design teams.
• Maintain traceability across hazards, risks, analyses, and controls.
• Prepare system/product risk management reports.
• Update risk management files annually and after post-market signals.
• Assist CAPA with links to Risk Management processes.
• Support audits and risk management process improvements.

Skills

Risk management

Quality tools/methodologies

Cross-functional collaboration

Analytical thinking

Documentation

Education

Bachelor's degree in Engineering or Technical Field

Advanced degree

Tools

FMEA

FTA

Job description

Abbott's Electrophysiology (EP) business in Saint Paul, MN is seeking a Staff Risk Management Engineer II to assure new products perform safely and meet quality requirements. You will partner with clinical, design, regulatory, and post-market teams to mitigate risk and safeguard patient safety while enabling business goals.

In this role you will develop risk management plans, support hazard analyses and risk assessments (FMEA/FTA), maintain traceability, and drive risk file updates.