Valve R&D Engineer – Transcatheter Heart Valve

Edwards Lifesciences; Irvine (CA); On-site; USD 87,000 - 123,000; Full time

Job summary

Edwards Lifesciences is seeking a skilled Implant R&D Engineer to advance THV products in a collaborative R&D setting. You will own test plans, analyze results, and contribute to indication expansions through cross-functional teamwork with Quality, Manufacturing, Regulatory, and Clinical Development.

The role emphasizes hands-on testing, data interpretation, and rigorous documentation to support product development and regulatory submissions. CA-based position with competitive pay and benefits.

Qualifications

• Bachelor's Degree in Engineering or Scientific field; 2 years experience required.
• Hands-on experience with test method development and fixture design.
• Experience in in-lab test execution and data analysis.
• Familiarity with ISO/FDA design control processes and regulatory submissions.

Responsibilities

• Own test plans evaluating transcatheter heart valve designs, delivering evidence of hemodynamic performance and durability.
• Interrogate intraprocedural valve performance and predict lifecycle performance.
• Author design verification plans, protocols, reports, and change submissions within Edwards' framework.
• Generate work instructions, test methods, and engineering drawings to establish specifications.
• Collaborate with cross-functional teams to understand anatomy-device interactions and develop test fixtures for indication expansion.
• Apply statistical techniques (ANOVA, regression, MSA) to interpret results and assess risk.
• Communicate findings in reports and presentations for regulatory submissions; write technical summaries for stakeholders.
• Document methodologies in compliance with internal standards and regulatory requirements.

Skills

Hands-on test method development

Fixture design

In-lab test execution

Data analysis

Education

Bachelor's Degree in Engineering or Scientific field

Master's Degree or equivalent with internship/thesis

Tools

MS Excel

Minitab

SolidWorks

Windchill

Job description

Edwards Lifesciences is seeking a skilled Implant R&D Engineer to advance THV products in a collaborative R&D setting. You will own test plans, analyze results, and contribute to indication expansions through cross-functional teamwork with Quality, Manufacturing, Regulatory, and Clinical Development.

The role emphasizes hands-on testing, data interpretation, and rigorous documentation to support product development and regulatory submissions. CA-based position with competitive pay and benefits.