Senior Risk & Quality Engineer - Medical Devices

Medtronic plc; United States; On-site; USD 98,000 - 148,000; Full time

Benefits offered by this job

Health, dental, vision insurance

401(k) plan with employer match

Tuition assistance

Job summary

Medtronic plc is seeking a Senior Risk Management Quality Engineer to lead risk management activities across the product lifecycle in the surgical operating unit. The role emphasizes DFMEA leadership, risk assessment, and regulatory compliance to ensure patient safety and high-quality medical devices.

Responsibilities include creating and maintaining risk management plans, reviewing design changes, and integrating risk control with product development and post-market surveillance.

Qualifications

• Bachelor’s degree in engineering or a related technical field.
• In-depth knowledge of FDA regulations, ISO 13485, ISO 14971, and other relevant standards.
• Strong analytical and problem‑solving skills with the ability to perform root-cause analysis.
• Excellent written and verbal communication, with cross‑functional collaboration.

Responsibilities

• Develop and maintain risk management strategies and files for product safety.
• Lead hazard and risk analyses, DFMEAs and risk control activities.
• Review product complaints and post‑market surveillance plans.
• Integrate risk management with design controls and regulatory compliance.
• Oversee design verification/validation activities and ensure proper documentation.

Skills

Risk management

DFMEA

Regulatory compliance

Root cause analysis

Cross-functional leadership

Analytical thinking

Education

Bachelor's degree in engineering

Advanced degree preferred

Job description

Medtronic plc is seeking a Senior Risk Management Quality Engineer to lead risk management activities across the product lifecycle in the surgical operating unit. The role emphasizes DFMEA leadership, risk assessment, and regulatory compliance to ensure patient safety and high-quality medical devices.

Responsibilities include creating and maintaining risk management plans, reviewing design changes, and integrating risk control with product development and post-market surveillance.