Quality Engineer

Confluent Medical Technologiesis dedicated to working collaboratively with our customers, taking projects from rapid prototype into high volume production.Our unparalleled technicalexpertise, proven experience and partnership with our clientshasallowed us to perfect the process necessary to deliver world-class medical devices through innovative material science,engineeringand manufacturing.

Our primary capabilitiesinclude: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’relooking for a QualityEngineer to join ourLaguna Niguel, CATeam!

As a uniquely qualified candidate, you will:

Ensure that compliancetocustomer, risk management,qualityand design control requirements isdemonstratedin design and development projects.  Help toensure 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 onscopeof work,selectionof materials/equipment/testmethodologyand length of tasks. Participate in decisions on design changes to meet revised specifications. Provide and develop solutions toproblems oflimited 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 inthe productdevelopment and design assurance areas. Familiarity with regulatory guidance documents and standards isrequired. 

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

• Implements methods and/or procedures for inspecting,testingand 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 processeshave adequate andappropriate processcontrols.   

• Responsible for taking the lead in generatingandmaintainingrisk management files supporting product developmentprojects, including Risk Management Plans/Reports, Hazard Analyses, FMEAs, Design Trace Matrices, Post Market Surveillance plans and other related documentsbased 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 AnalysisandANOVA.   

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

• Write Process Validation Protocols,analyzedataand write and release Process Validation Reports.   

• Interfacewith Customer as needed on Design and Development Responsibilities, Quality Issues andorSupplier Initiated Change Requests.   

• Support Hosting of External Customerand orNotified Body Audits as applicable.   

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

• Represent Quality Assurance for Non-Conformance Reportdispositions, andparticipate 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,techniciansand others whoassistin 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,safetyand environmental standards set by the company.   

EDUCATION and/or EXPERIENCE:

• BS in a related engineering discipline; and5years of related experience working in Quality in a medical device environment or equivalent combination of education and experience   

• MS in a related engineering discipline and4years of related experience working in Quality in a medical device environment or equivalent combination of education and experience   

• 5+years experiencein Medical Device Product Development

• 5+years experiencewith FDA, ISO13485and EU MDR Design Control requirements 

• Demonstrated knowledge of and practical application of ISO 14971 requirements

• Strong statistical data analysis skills using Minitab isa must, including process capability and data normality assessments, analysis of variance, hypothesis testing, determiningappropriate samplesizes, tolerance interval assessments,variable and attribute sampling plan applications,design of experiments (DOE) and response surface models 

• Competentin Microsoft Office applications

Confluent Medical Technologies offersvery competitivecompensation 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’sno better time to join Confluent! Qualified candidates will be contacted. No phone, fax or email inquiries from potential applicants, externalrecruitersor 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.