Senior Risk & Quality Engineer - Medical Devices

Medtronic plc; Lafayette, Minneapolis (CO, MN); Sur place; USD 110 000 - 160 000; Plein temps

Avantages offerts par ce poste

Onsite four days a week

Résumé du poste

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

The ideal candidate will have proven expertise in DFMEA, failure mode analysis, and post-market surveillance, ensuring patient safety remains central to development efforts. On-site collaboration is required.

Qualifications

• Experience with FDA regulations, ISO 13485, ISO 14971, and related standards.
• Ability to lead risk management activities across product lifecycle in a medical device setting.
• Proven skills in hazard analysis, DFMEA, and risk-based decision making.

Responsabilités

• Develop and maintain risk management plans, files, and reports with regular reviews.
• Lead DFMEA and analyze risks to implement effective controls and actions.
• Coordinate with cross-functional teams to ensure patient safety and design control compliance.
• Oversee post-market surveillance and regulatory audits as needed.

Connaissances

Risk management

DFMEA

Regulatory compliance

FDA regulations

ISO 13485

Design controls

Root cause analysis

Leadership

Formation

Bachelor's degree in engineering or related technical field

Description du poste

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

The ideal candidate will have proven expertise in DFMEA, failure mode analysis, and post-market surveillance, ensuring patient safety remains central to development efforts. On-site collaboration is required.