Engineer II R&D

Edwards Lifesciences Gruppe; Irvine (CA); On-site; USD 87,000 - 123,000; Full time

Job summary

Edwards Lifesciences Gruppe is seeking an Engineer II, R&D in Irvine to contribute to next-generation transcatheter therapies for aortic regurgitation. You will work with clinical, manufacturing and regulatory teams to translate physician and patient needs into innovative product solutions.

The role supports design verification, development of drawings and specs, and collaboration with suppliers to advance projects through the development lifecycle.

Qualifications

• Bachelor's degree in Engineering, or related field, with a minimum of 2 years of engineering experience, or Master's with relevant internship/research.
• Experience in medical device development or highly regulated environments is preferred.
• Strong communication and collaborative skills across cross-functional teams.

Responsibilities

• Contribute to design and development of next-gen transcatheter therapies for AR.
• Collaborate with clinicians, marketing, and stakeholders to translate needs into product solutions.
• Prepare and update design control documents, risk files, and verification protocols.

Skills

Engineering fundamentals

Data analysis

Design of experiments

Documentation

Cross-functional collaboration

CAD proficiency

Statistical analysis

Education

Bachelor's degree in Engineering

Master's degree in Engineering

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 ImpactContribute 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 experienceWhat Else We Look For (Preferred)Degree in Biomedical Engineering, Mechanical Engineering or Materials Engineering preferredExperience supporting medical device, biotechnology, healthcare, or other highly regulated product development environments.Medical device delivary system experienceDemonstrated 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). 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.