Senior Risk Management Quality Engineer - Medical Devices

Medtronic plc

Lafayette (CO)

On-site

USD 98,000 - 148,000

Full time

2 days ago

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Job summary

Medtronic plc is seeking a Senior Risk Management Quality Engineer for the surgical operating unit’s new product development quality team. The role emphasizes risk management, design controls, and regulatory compliance to embed patient safety across the product lifecycle.

The candidate will lead DFMEAs, manage risk files, and collaborate with cross-functional teams to ensure product quality and regulatory readiness.

Qualifications

Bachelor’s degree in engineering or related technical field.
Regulatory knowledge of FDA regulations and ISO standards (13485, 14971).
Strong problem-solving and analytical skills with ability to perform root-cause analysis.

Responsibilities

Collaborate cross-functionally to ensure product quality and patient safety.
Maintain risk management file, plans, reports, and conduct risk reviews.
Lead hazard and risk analyses (DFMEA) with project teams.
Review and analyze product complaints to prevent issues.
Integrate product security measures into risk management files.
Lead process FMEA/User FMEA development and integration.
Oversee design reviews and maintain risk management throughout product lifecycle.
Develop post-market surveillance plans to monitor safety and performance.
Lead field issue evaluations including root cause analysis and containment strategies.