Engineer II, R&D

Edwards Lifesciences•Irvine, CA

2d•$87,000 - $123,000

About The Position

Edwards Lifesciences is seeking an engineer for its Implant R&D team to support Transcatheter Heart Valve (THV) Commercial Portfolio Excellence initiatives. The role spans feasibility assessments, design verification testing, indication expansions, and Global Supply Chain scalability efforts. The engineer works closely with cross-functional partners to generate evidence and insights used to guide technical decisions, evaluate device performance, and improve patient outcomes. The position involves developing and owning test plans for transcatheter heart valve designs, including assessments of hemodynamic performance, durability, resistance to embolization, and interactions with delivery systems and patient anatomy under clinically relevant conditions. The engineer applies knowledge of transcatheter valve replacement techniques to assess intraprocedural performance and predict performance over the device’s intended lifecycle. The engineer authors and releases design verification plans, protocols, reports, and other documentation within the design control framework; executes testing; directs technicians; analyzes data; and develops work instructions, test methods, drawings, and prototypes to characterize product or process specifications. The role also involves collaborating on anatomy-device and device-device interactions, developing fixtures and methods for complex use conditions, applying statistical methods to test design and data interpretation, and communicating findings through technical reports, regulatory-submission materials, and presentations. Methodologies and findings must comply with internal standards and regulatory requirements.

Requirements

Bachelor’s degree in Engineering or a scientific field and at least 2 years of experience; or a Master’s degree or equivalent in Engineering or a scientific field with an internship, senior project, or thesis in an Engineering or scientific field.

Nice To Haves

Hands-on experience with test method development, fixture design, in-lab test execution, and data analysis.
Strong problem-solving and critical-thinking skills.
Excellent verbal communication and collaboration skills in a cross-functional environment, including proficiency with Microsoft PowerPoint.
Strong documentation and technical writing skills, including proficiency with Microsoft Word.
Familiarity with regulatory standards such as ISO and FDA requirements, and with design control processes.
Ability to work independently and as a team member and build productive internal and external working relationships.
Ability to manage competing priorities in a fast-paced environment.
Strong understanding of statistical techniques and engineering tools such as Microsoft Excel, Minitab, and SolidWorks.
Engineering experience in a regulated industry, preferably with cardiovascular implantable devices; experience testing heart valves in compliance with ISO 5840 is preferred.
Familiarity with product lifecycle management, document control, and Windchill.
Experience authoring deliverables for submissions to regulatory authorities, including the FDA.
Experience with CAD design and drawings and manufacturing techniques such as molding, machining, and 3D printing.
Experience with traditional engineering materials such as plastics and metals, as well as biomaterials such as pericardial tissue.

Responsibilities

Own test plans for evaluating transcatheter heart valve designs and generate evidence on hemodynamic performance, durability, embolization resistance, and interactions with delivery catheter systems and patient anatomy.
Apply knowledge of transcatheter valve replacement techniques to assess intraprocedural valve performance and predict performance throughout the device’s intended lifecycle.
Author and release design verification plans, protocols, and reports; execute tests; direct technicians; and analyze data.
Create work instructions, test methods, engineering drawings, and prototypes to establish or characterize product and process specifications.
Collaborate with experts to understand anatomy-device and device-device interactions and develop test fixtures and methods for complex and novel use conditions.
Work with Delivery System R&D, Manufacturing, Quality Engineering, Regulatory Affairs, and Clinical Development to align performance-assessment strategies, results, and interpretation.
Use statistical techniques and tools, including ANOVA, multivariate regression, and measurement system analysis, to design test strategies and interpret results and uncertainty.
Communicate findings through reports, technical summaries for regulatory submissions, presentations, and coordination with colleagues at all levels.
Document methodologies and findings in compliance with internal standards and regulatory requirements.