R&D Valve Engineer II – Heart Device Innovation

Edwards; Irvine (CA); Vor Ort; USD 87.000 - 123.000; Vollzeit

Zusammenfassung

Edwards Lifesciences is seeking a skilled engineer to join our Implant R&D team, advancing THV CPEx initiatives. You will lead test plans, generate critical data, and collaborate with Delivery System R&D, Manufacturing, Quality, Regulatory Affairs, and Clinical Development to drive device performance and patient outcomes.

You will conduct hands-on valve testing, support design verification, and help shape regulatory submissions while leveraging CAD, molding, and 3D printing techniques in a

Qualifikationen

• Bachelor's Degree in Engineering or Scientific field; 2 years experience required.
• Master's Degree or equivalent with internship, senior projects, or thesis in Engineering or Scientific field.

Aufgaben

• Own test plans for evaluating performance of transcatheter heart valve designs and generate credible evidence for hemodynamic performance, durability, embolization resistance, and interactions with delivery system under clinically relevant use conditions.
• Apply knowledge of transcatheter valve replacement techniques to interrogate intraprocedural valve performance and predict performance through the device lifecycle.
• Author documentation to support product development and change submissions within Edwards’ design control framework; write/ release design verification plans, protocols, execute tests, supervise technicians, analyze data, and author reports.
• Generate work instructions, test methods, and drawings/prototypes to establish/characterize product specifications.
• Collaborate with cross-functional experts to understand anatomy-device interactions and develop test fixtures/methods for complex use conditions to support indication expansion projects.
• Utilize CAD design and manufacturing knowledge (molding, machining, 3D printing) to support testing and development; familiarity with biomaterials is a plus.

Kenntnisse

Test method development

Fixture design

Data analysis

Statistical techniques

ISO FDA design control

Cross-functional collaboration

Ausbildung

Bachelor's Degree in Engineering or Scientific field

Master's Degree or equivalent with internship, senior projects, or thesis

Tools

SolidWorks

Windchill

MS Excel

Minitab

Jobbeschreibung

Edwards Lifesciences is seeking a skilled engineer to join our Implant R&D team, advancing THV CPEx initiatives. You will lead test plans, generate critical data, and collaborate with Delivery System R&D, Manufacturing, Quality, Regulatory Affairs, and Clinical Development to drive device performance and patient outcomes.

You will conduct hands-on valve testing, support design verification, and help shape regulatory submissions while leveraging CAD, molding, and 3D printing techniques in a