Engineer II R&D

Edwards Lifesciences; Irvine, Northern (CA, KY); Hybrid; USD 87,000 - 123,000; Full time

Job summary

Edwards Lifesciences in Irvine, CA is seeking an Engineer II, R&D to join the Transcatheter Heart Valve team. You will design, test, and document next-generation therapies for aortic regurgitation, collaborating with Clinical Affairs, Engineering, Manufacturing, and Quality to meet development milestones.

The role requires an engineering degree and 2+ years of relevant experience (or a master's with internship). CAD proficiency and strong data-driven problem solving are favored.

Qualifications

• Bachelor's or Master's degree in engineering with internship/project experience.
• Experience in medical device or regulated product development environments.
• Ability to apply engineering fundamentals to solve complex problems.
• Experience with design controls, risk management, verification and validation.

Responsibilities

• Contribute to the design, development, and advancement of next-generation transcatheter therapies for the treatment of aortic regurgitation.
• Partner with clinicians, marketing, and cross-functional stakeholders to translate physician and patient needs into innovative product solutions.
• Develop and execute engineering studies, verification activities, and test methods to evaluate product performance and support design decisions.
• Analyze experimental data, draw technical conclusions, and communicate recommendations to project teams and leadership.
• Create and refine engineering drawings, component specifications, prototypes, and design documentation to support product development milestones.
• Collaborate with suppliers to develop components and processes, establish specifications and tolerances, and define acceptance criteria.
• Support design verification readiness through component development, drawing reviews, and technical assessments.
• Author and update design control documentation, including product requirements, risk management files, protocols, reports, and specifications.
• Work closely with Manufacturing, Quality, Clinical Affairs, Regulatory Affairs, Operations, Marketing, Supplier Development, and Supplier Quality to advance projects through the product development lifecycle.

Skills

Engineering fundamentals

Medical device development

Data analysis

Documentation & communication

CAD proficiency

Statistical analysis

Cross-functional collaboration

Education

Bachelor's degree in Engineering or related field

Master's degree in Engineering or related field

Tools

SolidWorks

Creo

Microsoft Office

Job description

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.

We're dedicated to pioneering next-generation innovations for patients with aortic regurgitation (AR). Our Transcatheter Heart Valve (THV) business unit brings together Clinical Affairs, Engineering, and Research professionals to design and develop minimally invasive therapies that impact patient outcomes and quality of life. We're working together to transform cardiovascular care and device development to address unmet patient needs in structural heart disease. Join us as an Engineer II, R&D, and be part of our inspiring journey.

How You'll Make an Impact

• Contribute to the design, development, and advancement of next-generation transcatheter therapies for the treatment of aortic regurgitation.
• Partner with clinicians, marketing, and cross-functional stakeholders to translate physician and patient needs into innovative product solutions.
• Develop and execute engineering studies, verification activities, and test methods to evaluate product performance and support design decisions.
• Analyze experimental data, draw technical conclusions, and communicate recommendations to project teams and leadership.
• Create and refine engineering drawings, component specifications, prototypes, and design documentation to support product development milestones.
• Collaborate with suppliers to develop components and processes, establish specifications and tolerances, and define acceptance criteria.
• Support design verification readiness through component development, drawing reviews, and technical assessments.
• Author and update design control documentation, including product requirements, risk management files, protocols, reports, and specifications.
• Work closely with Manufacturing, Quality, Clinical Affairs, Regulatory Affairs, Operations, Marketing, Supplier Development, and Supplier Quality to advance projects through the product development lifecycle.
• Provide technical guidance to laboratory technicians, including test execution, training, and coordination of assigned activities.

What You'll Need (Required)

• Bachelor's degree in Engineering, or a related scientific field and a minimum of 2 years of relevant engineering experience - OR -
• Master's degree in Engineering or a related scientific field with applicable internship, research, thesis, capstone project, or industry experience

What Else We Look For (Preferred)

• Degree in Biomedical Engineering, Mechanical Engineering or Materials Engineering preferred
• Experience supporting medical device, biotechnology, healthcare, or other highly regulated product development environments.
• Medical device delivary system experience
• Demonstrated ability to apply engineering fundamentals to solve complex technical problems.
• Experience designing and executing experiments, analyzing data, and drawing data-driven conclusions.
• Familiarity with product development processes, including design controls, risk management, verification, and validation activities.
• Strong technical documentation and communication skills with the ability to collaborate effectively across functions and organizational levels.
• Experience working with suppliers and external partners to develop components or processes.
• Knowledge of statistical analysis techniques and engineering problem-solving methodologies.
• Experience developing engineering drawings, specifications, and test methods.
• Proficiency with Microsoft Office applications; experience with CAD software such as SolidWorks, Creo, or equivalent is preferred.
• Ability to manage multiple priorities and thrive in a fast-paced, collaborative environment.
• Strong attention to detail and commitment to quality.
• Knowledge of Edwards Quality System requirements and Environmental Health & Safety practices is a plus.

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).