Job Title - Quality Engineer I

Job Location - Miami Lakes, Florida

Job Description -

1. Medical device experience
2. Complaint handling experience preferred.
3. Product Risk Management experience/Post market quality experience preferred.

In this exciting role as Quality Engineer, you will develop, modify, apply, and maintain quality standards and protocols for post market analysis. Perform complex failure analysis of devices/components returned with alleged malfunctions. Collaborates with engineering, product development, complaint management, supplier quality and manufacturing functions to ensure returned product investigations fully address reported events. Develop and implement methods and procedures to assist in product analysis investigations. Provide direction for failure analysis technicians to ensure that field returns are evaluated appropriately to deliver clear investigation results and potential root causes for identified failures. Initiate discussions with management, Field Assurance, and QA when new failure mode(s) is(are) identified during failure analysis.

The HVAD System features the world's smallest, commercially available, centrifugal flow pump.

• 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, batterie 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.