Quality Engineer II - Miami Lakes, FL

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 and requires on-site presence three days a week.

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

Must Have: Minimum Requirements

TO BE CONSIDERED FOR THIS ROLE, PLEASE BE SURE THE MINIMUM REQUIREMENTS ARE EVIDENT ON YOUR RESUME

• Bachelor’s degree in Engineering, Science, or related technical discipline
• Minimum of 2 years of relevant experience in Engineering and/or Quality or advanced degree in Engineering, Science, or technical field with 0 years of relevant work experience in Quality and/or Engineering
  
  
  

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
• Six sigma green belt or black belt certification.
  
  
  

About Medtronic

Together, we can change healthcare worldwide. At Medtronic, we push the limits of what technology, therapies and services 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.

We want to accelerate and advance our ability to create meaningful innovations - but we will only succeed with the right people on our team. Let’s work together to address universal healthcare needs and improve patients’ lives. Help us shape the future.

Physical Job Requirements

The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. For Office Roles: While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer and communicate with peers and co-workers. Contact your manager or local HR to understand the Work Conditions and Physical requirements that may be specific to each role. (ADA-United States of America)

A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create.  We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage. Learn more about our benefits here .

This position is eligible for a short-term incentive plan.  Learn more about Medtronic Incentive Plan (MIP) here .

The provided base salary range is used nationally (except in certain CA locations). The rate offered is compliant with federal/local regulations and may vary by experience, certification/education, market conditions, location, etc. 

Base pay is based on numerous factors and may vary depending on job-related knowledge, skills, and experience .