Senior Quality & Risk Engineer – Medical Devices

Medtronic plc; Lafayette, Northern (CO, KY); Hybrid; USD 98,000 - 148,000; Full time

Job summary

Medtronic plc is seeking a Senior Risk Management Quality Engineer to lead risk management activities within the surgical operating unit of the new product development quality team. The role focuses on risk analysis, design controls, regulatory compliance, and patient safety across the product lifecycle.

The ideal candidate has strong risk management experience in medical devices, ability to mentor teams, and a track record of improving quality systems.

Qualifications

• Bachelor’s degree in engineering or related technical field.
• In-depth knowledge of FDA regulations, ISO 13485 and ISO 14971, and other relevant standards.
• Strong analytical and problem-solving abilities with rigorous root-cause analysis.
• Excellent written and verbal communication; ability to collaborate with cross-functional teams.
• Proven leadership and project management skills with ability to lead multiple projects.

Responsibilities

• Develop and maintain risk management strategies and plans.
• Lead hazard and risk analyses (DFMEAs) with project teams.
• Review product complaints and perform root-cause analysis.
• Ensure regulatory compliance and participate in audits/regulatory inspections.
• Lead and mentor teams in quality system processes and standards.

Skills

Risk management

Regulatory knowledge

Design controls

Leadership

Communication

Problem solving

Education

Bachelor’s degree in engineering

Job description

Medtronic plc is seeking a Senior Risk Management Quality Engineer to lead risk management activities within the surgical operating unit of the new product development quality team. The role focuses on risk analysis, design controls, regulatory compliance, and patient safety across the product lifecycle.

The ideal candidate has strong risk management experience in medical devices, ability to mentor teams, and a track record of improving quality systems.