Quality Engineer II - MCS

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

We anticipate the application window for this opening will close on - 23 Oct 2026

Careers that change lives start here. Medtronic is a global leader in healthcare technology with a Mission to alleviate pain, restore health, and extend life. Our 95,000 employees work across more than 150 countries to put patients first - developing innovative medical technologies that improve the lives of 72+ million patients each year. Your unique talents will help shape the future of healthcare while building a career grounded in purpose, growth, and impact.

A Day in the Life

Quality Engineer II

Careers that Change Lives

We value what makes you unique. Together, we can change healthcare worldwide. At Medtronic, we push the limits of what technology can do to help alleviate pain, restore health, and extend life. We challenge ourselves and each other to make tomorrow better than yesterday. It is what makes this an exciting and rewarding place to be. Be a part of a company that thinks differently to solve problems, make progress, and deliver meaningful innovations.

Medtronic Mechanical Circulatory Support (MCS) is seeking a Quality Engineer II to join the MCS Complaint Investigation team to perform complex failure analysis of devices/components returned with alleged malfunctions, collaborate with engineering, product development, complaint management, supplier quality and manufacturing functions to ensure returned product investigations fully address reported events and to develop and implement methods and procedures to assist in product analysis investigations.

This position is in Miami Lakes, FL. within the Mechanical Circulatory Support (MCS) operating unit. At Medtronic, we bring bold ideas forward with speed and decisiveness to put patients first in everything we do. In-person exchanges are invaluable to our work. We are working on-site 4 days per week as part of our commitment to fostering a culture of professional growth and cross-functional collaboration as we work together to engineer the extraordinary. This role will require less than 10% of travel to enhance collaboration and ensure successful completion of projects.

We believe that when people from different cultures, genders, and points of view come together, innovation is the result -and everyone wins. Medtronic walks the walk, creating an inclusive culture where you can thrive.

A Day in the Life

In general, the following responsibilities apply for the Quality Engineer II role. This includes, but is not limited to the following:

• Collaborates with engineering and manufacturing functions to ensure quality standards are in place.
• Ensures that corrective measures meet acceptable reliability standards, and that documentation is compliant with requirements.
• May specialize in the areas of design, incoming material, production control, product evaluation and reliability, inventory control and/or research and development as they apply to product or process quality.
• Completes comprehensive review of HVAD log files to determine correlation between the reported event and electro-mechanic components.
• Reviews HVAD system testing results including but not limited to: profilometer measurements, front/back impeller pre-loads, axial gap measurements, in-vitro wet-test functional parameters, and stators conductivity results to determine a most probable root cause associated with a reported event.
• Determines potential interaction between reported event and all HVAD system components controller, batteries, pump, monitor, AC adapter, battery charger, and surgical tools.
• Generates comprehensive HVAD product investigation reports to support findings, root cause, regulatory requirements and obtains the necessary release approvals.
• Creates and develops engineering projects for improvements of analysis/investigation process to eliminate process waste and reduce rework rates.
• Initiates the required escalation to Supply Quality disclosing potential manufacturing issues and lead the required actions and/or supplemental testing to provide the needed facts and discoveries to sustain the manufacturing related defect.

Qualifications

Must Have: Minimum Requirements

• Bachelor's degree in science, technology, engineering, or math and a minimum of 2 years of technical work experience; or an advanced degree in science, technology, engineering, or math with 0 years of technical experience.

Nice to Have

• Exposure to quality engineering best practices and timely resolution of nonconforming product issues.
• Demonstrated track record of communicating effectively with internal and external employees, customers, and vendors regarding ongoing operations.
• Uses information exchange, influence, and active persuasion without direct exercise of command to gain cooperation of supporting functions.
• Familiarity with medical device regulations and good manufacturing practices
• Experience with VADs