Quality Engineer I - MCS

Medtronic•Miami Lakes, FL

1d•$66,400 - $99,600•Onsite

About The Position

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 I to join the MCS Complaint Investigation team, to develop, modify, apply and maintain quality standards while managing the analysis processes, ensuring complex failure analysis of devices/components returned with alleged malfunctions are performed by those standards and meet HeartWare regulatory requirements. Collaborate with engineering, product development, complaint management, supplier quality and manufacturing functions to ensure returned product investigations fully address reported events. Develop and implement methods, procedures and tools in a project management capacity, aimed in assisting in product analysis investigations performance improvement. 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.

Requirements

Bachelor’s degree in science, technology, engineering, or math and 0 years of experience

Nice To Haves

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
Six sigma green belt or black belt certification.
Root Cause analysis methodology certification.

Responsibilities

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.
Participates and/or conducts validation or qualifications tests of new or existing failure analysis equipment in accordance with internal procedures.