Edwards Lifesciences Engineer II, R&D - Transcatheter Heart Valve in Irvine, California
This is an exciting opportunity for an Engineer II within the Transcatheter Heart Valve (THV) R&D Valve Testing Group. As part of this team, you will be responsible for supporting R&D activities for THV R&D Valve Testing, legacy product modifications and THV R&D Valve Testing laboratory operations.
Job Functions / Responsibilities:
Support a range of laboratory engineering activities with focus on THV R&D Valve Testing and legacy product modification including feasibility evaluations, product design verification, test method validation, and equipment validation (e.g. standard and custom test equipment).
Design, develop, and qualify LabVIEW based software, test fixturing / tooling, test equipment and/or test methods to be used in device qualification testing including writing and executing protocols, statistical data analysis and authoring reports.
Partner with THV R&D engineers and Clinical Team for device development including rapidly prototyping designs, evaluating materials, troubleshooting failures, proposing and evaluating design improvements.
Identify opportunities for design / re-desig, test equipment, tools, fixtures, or software etc. to improve existing test methods and lab processes.
Develop and execute feasibility studies, equipment qualification, test method, equipment/software validation and / or product verification protocols / reports and technical reports. May also be responsible for developing test methods and test strategies.
May create, update and optimize laboratory test methods and standard operating procedures.
Employ use of statistical analysis techniques and statistical experimental design, as appropriate.
Bachelor's degree in Mechanical Engineering, Biomedical Engineering or Chemical Engineering, or related engineering discipline
2+ years’ experience in medical device or similar regulated industry
Proficiency in advanced 3D CAD modelling (Solidworks) using curves and surfaces and in development and patient specific models - hands on experience in mold development - strong prototyping skills are required
Prior work experience in a lab environment with flow, pressure, leak, tensile, thermal and other test instrumentation is required
Must have a good understanding of heart anatomy
Solid understanding and knowledge of engineering principles, theories, and concepts / working knowledge and understanding of statistical techniques is required
Proficiency in Microsoft Office Suite and Minitab is required
Capability to quickly learn and interpret complex test systems is required
Ability to work well both independently and as a member of a cross-functional team in a dynamic environment is essential
Must be able to effectively articulate, verbally and in writing, results and conclusions to technical and non-technical personnel
Must be a highly motivated self-starter who is driven to achieve quality and value-add results with appropriate direction - must seek direction when appropriate
Master's Degree or equivalent in Engineering
Experience in medical device testing and development, software development for LabVIEW cRio system, equipment and software validation and test method validation is strongly preferred
Working knowledge in heart valve hydrodynamic testing per ISO 5840 is strongly preferred
Working knowledge in developing and maintaining LabVIEW cRIO systems with large number of sensors, such as pressure, flow, thermal and high-speed imaging instrumentation preferred
Previous exposure to Automated Test System, LabVIEW RealTime, MATLAB, and Linux OS is highly desirable
Solid problem-solving, organizational, analytical and critical thinking skills
Excellent teamwork and interpersonal skills including negotiating and relationship management
Clear understanding of good documentation practices and medical device quality system regulations and requirements
Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.
Edwards Lifesciences is the global leader in patient-focused medical innovations for structural heart disease, as well as critical care and surgical monitoring. Driven by a passion to help patients, the company collaborates with the world's leading clinicians and researchers to address unmet healthcare needs, working to improve patient outcomes and enhance lives. Headquartered in Irvine, California, Edwards Lifesciences has extensive operations in North America, Europe, Japan, Latin America and Asia and currently employs over 15,000 individuals worldwide.
For us, helping patients is not a slogan - it's our life's work. From developing devices that replace or repair a diseased heart valve to creating new technologies that monitor vital signs in the critical care setting, we focus on helping patients regain and improve the quality of their life.