Engineer II, R&D

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

USA - California - Irvine

Full time

Req-51415

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 measurement system analysis (MSA) to interpret empirical results with an understanding of the associated uncertainty and implications for hypothesis testing.
• Communicate your ideas and findings effectively including authoring reports and technical summaries for regulatory submissions, preparing and delivering presentations to cross-functional stakeholders, and collaborating and coordinating with colleagues at all levels including other engineers, technicians, and leadership.
• Document methodologies and findings in compliance with internal standards and regulatory requirements.

What You'll Need (Required)

• Bachelor's Degree in Engineering or Scientific field, 2 years experience Required

OR

• Master's Degree or equivalent in Engineering or Scientific field with internship, senior projects, or thesis in Engineering or Scientific field

What Else We Look For (Preferred)

• 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 MS PowerPoint.
• Strong documentation and technical writing skills including proficiency with Microsoft Word.
• Familiarity with regulatory standards (ISO, FDA) and design control processes.
• Ability to work well independently and as a team member & build productive internal/external working relationships.
• Ability to manage competing priorities in a fast paced environment.
• Strong understanding of statistical techniques and engineering tools such as MS Excel, Minitab, and SolidWorks.
• Engineering experience in a regulated industry, preferably in cardiovascular implantable devices. Experience with testing heart valves in compliance with the ISO 5840 standard is preferred.
• Familiarity with product lifecycle management (PLM), document control, and Windchill.
• Experience with authoring deliverables require for regulatory submissions to regulatory authorities including the FDA.

Aligning our overall business objectives with performance, we offer competitive salaries, performance-based incentives, and a wide variety of benefits programs to address the diverse individual needs of our employees and their families.

For California (CA), the base pay range for this position is $87,000 to $123,000(highly experienced).

The pay for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience). Applications will be accepted while this position is posted on our Careers website.

Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.

Edwards Lifesciences is the leading global structural heart innovation company, driven by a passion to improve patient lives. Through breakthrough technologies, world-class evidence and partnerships with clinicians and healthcare stakeholders, our employees are inspired by our patient-focused culture to deliver life-changing innovations to those who need them most.