Senior Risk & Quality Engineer – Medical Devices

Medtronic plc; Lafayette (CO); On-site; USD 98,000 - 148,000; Full time

Job summary

Medtronic plc, a global leader in medical technology, seeks a Senior Risk Management Quality Engineer to join the new product development quality team within the surgical operating unit. The role focuses on risk management, design controls, and regulatory compliance throughout the product lifecycle.

You will lead DFMEAs, manage risk files, and ensure patient safety while collaborating across functions to deliver high-quality medical devices in a fast-paced environment.

Qualifications

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

Responsibilities

• Collaborate cross-functionally to ensure patient safety and product quality.
• Create and maintain the risk management file, plans, and reports; conduct risk reviews.
• Lead hazard and risk analyses to identify and mitigate risks.
• Lead DFMEA activities with project teams to evaluate failure modes.
• Analyze product complaints to anticipate and prevent issues.
• Integrate product security measures into risk management efforts.
• Support Process FMEA/User FMEA integration into risk management.
• Lead design reviews and maintain risk management throughout the lifecycle.
• Develop and manage post-market surveillance plans for field performance.

Skills

Quality engineering

Risk management

Regulatory compliance

FDA/ISO knowledge

Leadership

Problem solving

Communication

Education

Bachelor's in engineering

Tools

Quality management systems

Statistical analysis

Regulatory standards

Job description

Medtronic plc, a global leader in medical technology, seeks a Senior Risk Management Quality Engineer to join the new product development quality team within the surgical operating unit. The role focuses on risk management, design controls, and regulatory compliance throughout the product lifecycle.

You will lead DFMEAs, manage risk files, and ensure patient safety while collaborating across functions to deliver high-quality medical devices in a fast-paced environment.