Quality Technician V - MCS

Quality Technician V – Mechanical Circulatory Support (MCS) Complaint Investigation Team

Location:

Miami Lakes, FL, United States

As a Quality Technician V, you will perform complex failure analysis of devices and components returned with alleged malfunctions. You will collaborate with engineering, product development, complaint management, supplier quality, and manufacturing to ensure thorough investigations and develop improvements to analysis methods and procedures.

• Collaborate with engineering and manufacturing functions to ensure quality standards are in place.
• Ensure corrective measures meet reliability standards and documentation complies with regulatory requirements.
• Specialize in areas such as design, incoming material, production control, product evaluation, reliability, inventory control, or R&D as related to product or process quality.
• Complete comprehensive review of HVAD log files to determine correlation between reported events and electro‑mechanic components.
• Review HVAD system testing results, including profilometer measurements, impeller pre‑loads, gap measurements, in‑vitro wet‑test parameters, and stator conductivity results to identify probable root causes.
• Determine potential interactions between reported events and all HVAD system components (controller, batteries, pump, monitor, AC adapter, charger, surgical tools).
• Generate comprehensive HVAD product investigation reports to support findings, root causes, regulatory compliance, and obtain necessary release approvals.
• Create and develop engineering projects to improve analysis and investigation processes, reducing waste and rework.
• Participate in or conduct validation or qualification tests of new or existing failure analysis equipment.

• High school diploma.
• Minimum 15 years of technical experience in a quality or engineering role.

• Experience with quality engineering best practices and resolving nonconforming product issues.
• Effective communication with internal and external stakeholders.
• Ability to influence without direct authority.
• Familiarity with medical device regulations and GMP.
• Experience with ventricular assist devices (VADs).
• Six Sigma Yellow Belt certification.
• Root cause analysis methodology certification.

Work is based in Miami Lakes, FL. The position requires outside‑office presence 4 days per week and less than 10% travel to support project completion.

Medtronic is an equal employment opportunity employer. We provide an inclusive workplace and reasonable accommodations for qualified individuals with disabilities. We do not discriminate on the basis of age, color, national origin, citizenship status, disability, race, religion, creed, gender, sex, sexual orientation, gender identity or expression, genetic information, marital status, public assistance status, veteran status, or any other characteristic protected by law.