Quality Engineer, Senior Staff

Confluent Medical Technologies is dedicated to working collaboratively with our customers, taking projects from rapid prototype into high volume production. Our unparalleled technical expertise, proven experience and partnership with our clients has allowed us to perfect the process necessary to deliver world-class medical devices through innovative material science, engineering and manufacturing. Our primary capabilities include: Nitinol components, balloon catheters, delivery systems, biomedical textiles, access kits, and guidewires. We take pride in our position as the leader in the medical technology space and are driven by a passion to create products that our clients have envisioned for their customers.  

We’re looking for a Staff Quality Engineer to join our Laguna Niguel, CA Team! 

As a uniquely qualified candidate, you will:   

Ensure that compliance to customer, risk management, quality and design control requirements is demonstrated in design and development projects.  Help to ensure successful transfer of the design to manufacturing.   

Work on problems and projects of moderate to complex scope where analysis of situation or data requires a review of identifiable factors, knowledge of industry regulations and best practices, and critical thinking skills. Participate in decisions on scope of work, selection of materials/equipment/test methodology and length of tasks. Participate in decisions on design changes to meet revised specifications. Provide and develop solutions to problems of limited to moderate scope.    

ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned.    

• Work requires a broad knowledge of precedents, principles and practices in the product development and design assurance areas. Familiarity with regulatory guidance documents and standards is required.  

• Responsible as part of a cross-functional team for developing, applying, revising and maintaining quality and regulatory standards for designing and processing materials/products into partially or finished medical device products.    

• Implements methods and/or procedures for inspecting, testing and evaluating the precision and accuracy of products and/or production equipment.    

• Diagnose and resolve manufacturing and quality system issues.    

• Participate in performing design reviews and pre-validation assessments to ensure the processes have adequate and appropriate process controls.    

• Responsible for taking the lead in generating and maintaining risk management files supporting product development projects, including Risk Management Plans/Reports, Hazard Analyses, FMEAs, Design Trace Matrices, Post Market Surveillance plans and other related documents