Engineer II, R&D

Edwards Lifesciences • Irvine, CA

1d

About The Position

Edwards Lifesciences is seeking an engineer to join its Implant R&D team and support Transcatheter Heart Valve (THV) Commercial Portfolio Excellence initiatives. The role contributes to feasibility assessments, design verification testing, indication expansions, and Global Supply Chain scalability efforts. The engineer partners with cross-functional teams to generate data and insights that inform technical decisions, device performance, and patient outcomes.

The position focuses on planning and performing hands-on testing of transcatheter heart valve designs under clinically relevant conditions. It includes evaluating hemodynamic performance, durability, resistance to embolization, and interactions among valves, delivery catheter systems, and patient anatomy. The engineer applies knowledge of transcatheter valve replacement techniques to assess intraprocedural performance and predict device performance over its intended lifecycle.

The engineer creates and releases design verification plans and protocols, executes tests, directs technicians, analyzes data, and writes reports. The role also involves developing work instructions, test methods, engineering drawings, prototypes, fixtures, and methods to characterize product or process specifications and challenge valve performance in complex use conditions. The engineer collaborates with cross-functional partners and subject-matter experts, uses statistical methods to design and interpret testing, and communicates findings through technical documentation and presentations. Methodologies and findings must comply with internal standards and regulatory requirements.

Requirements

• Bachelor’s degree in an engineering or scientific field and 2 years of experience; or a master’s degree or equivalent in an engineering or 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, including ISO and FDA requirements, and 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 cardiovascular implantable devices.
• Experience testing heart valves in compliance with ISO 5840.
• Familiarity with product lifecycle management, document control, and Windchill.
• Experience authoring deliverables required for regulatory submissions to 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 design performance.
• Generate evidence to assess hemodynamic performance, durability, resistance to embolization, and interactions with delivery catheter systems and patient anatomy under clinically relevant use conditions.
• Apply knowledge of transcatheter valve replacement techniques to evaluate intraprocedural valve performance and predict performance over the device’s intended lifecycle.
• Author product development and product change assessment documentation within Edwards’ design control framework.
• Write and release design verification plans and protocols, execute tests, direct technicians, analyze data, and author reports.
• Generate 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 use data to develop test fixtures and methods for complex use conditions and indication expansion projects.
• Work with Delivery System R&D, Manufacturing, Quality Engineering, Regulatory Affairs, and Clinical Development to align on performance assessment strategies, results, and interpretation.
• Use statistical techniques to design test strategies with an appropriate level of confidence based on risk.
• Apply statistical tools, including ANOVA, multivariate regression, and measurement system analysis, to interpret empirical results and their uncertainty and implications for hypothesis testing.
• Communicate findings through reports, technical summaries for regulatory submissions, and presentations to cross-functional stakeholders; coordinate with colleagues at all levels.
• Document methodologies and findings in compliance with internal standards and regulatory requirements.

Benefits

• Competitive salaries
• Performance-based incentives
• A wide variety of benefits programs to address the diverse individual needs of employees and their families

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level