Quality Engineer II – Medical Device Failure Analysis

Medtronic plc; Florida; On-site; USD 79,000 - 119,000; Full time

Job summary

Medtronic plc in Miami Lakes, FL is seeking a Quality Engineer II to join the MCS Complaint Investigation team. You will perform complex failure analyses on devices/components returned for alleged malfunctions, collaborating with engineering, product development, supplier quality and manufacturing to ensure thorough investigations.

The role emphasizes adherence to quality standards, regulatory compliance, and continuous improvement.

Qualifications

• Bachelor’s degree in STEM; or advanced degree with minimal experience.
• Exposure to quality engineering best practices and nonconforming issues.
• Proven communication with internal/external stakeholders.
• Familiarity with medical device regulations and GMP.
• Experience with VADs.
• Six Sigma Green/Black Belt certification.

Responsibilities

• Collaborates with engineering and manufacturing to ensure quality standards are in place.
• Ensures corrective measures meet reliability standards and documentation is compliant.
• May specialize in design, incoming material, production control, product evaluation and reliability.

Skills

Quality engineering

Communication

Regulatory knowledge

VADs

Six Sigma belt

Education

B.S./M.S. in STEM

Job description

Medtronic plc in Miami Lakes, FL is seeking a Quality Engineer II to join the MCS Complaint Investigation team. You will perform complex failure analyses on devices/components returned for alleged malfunctions, collaborating with engineering, product development, supplier quality and manufacturing to ensure thorough investigations.

The role emphasizes adherence to quality standards, regulatory compliance, and continuous improvement.