Quality Engineer II, Medical Device Failure Analysis

Medtronic plc; Miami (FL); Hybrid; USD 85,000 - 110,000; Full time

Job summary

Medtronic plc in Miami Lakes, FL seeks a Quality Engineer II to join the MCS Complaint Investigation team and perform complex failure analysis on devices and components returned with alleged malfunctions.

You will collaborate with engineering, product development, complaint management, supplier quality and manufacturing to ensure investigations address reported events and to develop methods to aid analysis.

Qualifications

• Bachelor’s degree in STEM with 2+ years technical experience, or an advanced degree with 0 years experience.
• Exposure to medical device quality practices is desirable.
• Strong communication with internal/external stakeholders.

Responsibilities

• Collaborate with engineering and manufacturing to ensure quality standards.
• Analyze HVAD log files to correlate events with components.
• Prepare HVAD investigation reports covering root cause and regulatory needs.
• Develop projects to improve analysis/investigation processes and reduce waste.
• Escalate to Supply Quality for manufacturing issues and drive testing.

Skills

Quality engineering

Cross-functional collaboration

Regulatory awareness

Problem solving

Education

Bachelor's degree in STEM or related field; or advanced degree

Tools

HVAD system testing

Profilometer

Job description

Medtronic plc in Miami Lakes, FL seeks a Quality Engineer II to join the MCS Complaint Investigation team and perform complex failure analysis on devices and components returned with alleged malfunctions.

You will collaborate with engineering, product development, complaint management, supplier quality and manufacturing to ensure investigations address reported events and to develop methods to aid analysis.