Quality Engineer, 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 based on translation of customer product requirements. 

• Provide guidance and generate reports for topics involving statistical analysis, including sample size requirements, process capability analysis, regression analysis, tolerance Interval Analysis and ANOVA.    

• Support Product/ Process Development Engineering in Optimization activities by guiding Design of Experiments of various process parameters and analyzing data.    

• Write Process Validation Protocols, analyze data and write and release Process Validation Reports.    

• Interface with Customer as needed on Design and Development Responsibilities, Quality Issues and or Supplier Initiated Change Requests.    

• Support Hosting of External Customer and or Notified Body Audits as applicable.    

• Investigate and manage customer field complaints, SCAR’s and internal CAPA’s as needed.    

• Represent Quality Assurance for Non-Conformance Report dispositions, and participate in monthly Oversight Review Boards as needed.    

• Provide training on quality system procedures and industry regulations/best practices. 

• May technically supervise or coordinate work of engineers, draftspersons, technicians and others who assist in specific assignments. 

• Follows all safety and production standard operating procedures.    

• Responsible for ensuring personal and company compliance with all Federal, State, local and company regulations, policies and procedures for Health, Safety and Environmental compliance. Responsible for the purchase or design of equipment that meets health, safety and environmental standards set by the company.    

EDUCATION and/or EXPERIENCE:    

• BS in a related engineering discipline; and 5 years of related experience working in Quality in a medical device environment or equivalent combination of education and experience    

• MS in a related engineering discipline and 4 years of related experience working in Quality in a medical device environment or equivalent combination of education and experience    

• 5+ years experience in Medical Device Product Development 

• 5+ years experience with FDA, ISO 13485 and EU MDR Design Control requirements  

• Demonstrated knowledge of and practical application of ISO 14971 requirements 

• Strong statistical data analysis skills using Minitab is a must, including process capability and data normality assessments, analysis of variance, hypothesis testing, determining appropriate sample sizes, tolerance interval assessments, variable and attribute sampling plan applications, design of experiments (DOE) and response surface models  

• Competent in Microsoft Office applications 

Confluent Medical Technologies offers very competitive compensation and benefits and is proud to have a distinguished reputation throughout the medical device industry around the world! We welcome eager and ambitious team players to apply. There’s no better time to join Confluent! Qualified candidates will be contacted. No phone, fax or email inquiries from potential applicants, external recruiters or other interested parties, please.  

We regret that we are unable to sponsor employment visas or consider individuals on a time-limited visa status for this position. 

Transforming Concepts into Reality  

Confluent Medical Technologies is an equal opportunity employer.