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Engineer II, R&D

Job in Irvine, Orange County, California, 92713, USA
Listing for: Edwards Lifesciences Gruppe
Full Time position
Listed on 2026-10-22
Job specializations:
  • Engineering
    Quality Engineering, Biomedical Engineer
Salary/Wage Range or Industry Benchmark: 87000 - 123000 USD Yearly USD 87000.00 123000.00 YEAR
Job Description & How to Apply Below
Innovation starts from the heart. At Edwards, we put patients first. We invest a significant proportion of our revenue towards research and development to drive and develop groundbreaking medical innovations for structural heart disease. As part of our R&D Engineering team, you will work closely with our Quality and Manufacturing teams to develop the latest tools and technologies to address significant, unmet clinical needs that impact patients’ lives around the world.

Aortic stenosis impacts millions of people globally, yet it often remains under-diagnosed and under-treated. Edwards’ groundbreaking work in transcatheter aortic heart valve replacement (TAVR) pioneered an innovative, life-changing solution for patients by offering heart valve replacement without the need for open heart surgery. Our Transcatheter Heart Valve (THV) business unit continues to partner with cardiologists and clinical teams to transform patient care with devices supported by clinical evidence.

It’s our driving force to help patients live longer and healthier lives. Join us and be part of our inspiring journey.

How You'll Make an Impact Edwards Lifesciences is seeking a highly skilled engineer to join our Implant R&D team playing a key role in advancing THV Commercial Portfolio Excellence (CPEx) initiatives, supporting activities ranging from feasibility assessments and design verification (DV) testing to indication expansions and Global Supply Chain (GSC) scalability efforts. By partnering closely with cross-functional teams, you will generate critical data and insights that drive technical decisions, shape device performance, and ultimately improve patient outcomes.

This position offers a unique blend of hands-on valve testing, product development, and innovation-focused engineering activities within a highly collaborative R&D organization.

Own test plans for evaluating the performance of transcatheter heart valve designs. Deliver credible evidence enabling assessment of hemodynamic performance, durability, resistance to embolization, and interactions with delivery catheter system and patient anatomy under clinically relevant use conditions.

Apply knowledge of transcatheter valve replacement techniques to interrogate intraprocedural valve performance and predict valve performance throughout the intended lifecycle of the device.

Author documentation to support product development and product change assessment submissions within Edwards’ design control framework. You will write and release design verification plans, protocols, execute tests, direct the activities of technicians, analyze data, and author reports.

Generate work instructions, test methods, engineering drawings/prototypes, etc. to establish/characterize product and/or process specifications.

Collaborate with experts to develop an understanding of anatomy-device and device-device interactions. Use this data to develop test fixtures and methods to challenge valve performance under complex and novel use conditions to support indication expansion projects.

Experience with CAD design and drawings as well as manufacturing techniques (molding, machining, 3D printing) is preferred.

Experience with traditional engineering materials (plastics, metals, etc.) as well as biomaterials (pericardial tissue) is preferred.

Collaborate effectively with cross-functional partners including Delivery System R&D, Manufacturing, Quality Engineering, Regulatory Affairs, and Clinical Development to ensure alignment on performance assessment strategies, results, and interpretation.

Employ statistical techniques to design test strategies to with the appropriate level of confidence based on an assessment of risk. Use statistical tools such as ANOVA, multivariate regression, and…
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