Lead Quality & Risk Engineer, Medical Devices

Medtronic plc

Lafayette, Northern (CO, KY)

Hybrid

USD 121,000 - 181,000

Full time

14 days+

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Benefits offered by this job

Health insurance

401(k) plan and match

Paid time off

Job summary

Medtronic plc is seeking a Principal Risk Management Quality Engineer for the Surgical Operating Unit within the New Product Development Quality Team. The role focuses on risk management, design controls, and regulatory compliance to ensure patient safety across the product lifecycle.

Qualifications include a Bachelor’s degree in engineering, FDA/ISO knowledge, strong problem-solving, and leadership abilities.

Qualifications

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

Responsibilities

Develop and maintain risk management strategies including risk plans and reports.
Lead hazard and risk analyses to identify risks and implement controls.
Run DFMEAs with project teams to evaluate failure modes and impacts.
Review product complaints to anticipate and prevent issues.
Integrate product security considerations into risk management documentation.
Oversee design validation/verification activities and maintain traceability between risk, requirements, and design outputs.