Senior Risk & Quality Engineer, Medical Devices

Medtronic; North Haven (CT); On-site; USD 121,000 - 181,000; Full time

Benefits offered by this job

Health insurance

401(k) with employer match

Paid time off

Tuition assistance/reimbursement

Job summary

Medtronic is seeking a Principal Risk Management Quality Engineer to lead risk management activities within the new product development quality group. The role focuses on design controls, regulatory compliance, and patient safety across the product lifecycle in a busy medical device environment.

The position requires strong collaboration across functions, expertise in DFMEAs, FMEAs, and post-market surveillance, and the ability to drive robust risk reduction in a fast-paced, onsite setting in

Qualifications

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

Responsibilities

• Develop and maintain risk management strategies for product safety.
• Lead DFMEAs and hazard analyses with project teams.
• Review and analyze product complaints to prevent issues.
• Ensure traceability between risk management and design outputs.
• Oversee post-market surveillance plans and field issue evaluations.

Skills

Problem-solving

Communication

Leadership

Regulatory knowledge

Education

Bachelor's degree in engineering

Advanced degree preferred

Tools

Quality Management Systems (QMS)

Risk management

Requirements management tools

Job description

Medtronic is seeking a Principal Risk Management Quality Engineer to lead risk management activities within the new product development quality group. The role focuses on design controls, regulatory compliance, and patient safety across the product lifecycle in a busy medical device environment.

The position requires strong collaboration across functions, expertise in DFMEAs, FMEAs, and post-market surveillance, and the ability to drive robust risk reduction in a fast-paced, onsite setting in