Senior Engineer, R&D

Edwards Lifesciences Gruppe; United States; On-site; USD 108,000 - 153,000; Full time

Benefits offered by this job

Competitive salaries

Performance-based incentives

Benefits programs

Job summary

Edwards Lifesciences is seeking an R&D Engineer to contribute to the design and development of next-generation transcatheter therapies for aortic regurgitation. You will work closely with Clinical Affairs, Quality, and Manufacturing to drive product development milestones.

The role requires a strong engineering background, experience in design controls, verification, and strong documentation skills. Candidates should be prepared for on-site work in Irvine, CA, within a 50-mile radius.

Qualifications

• Bachelor's degree in Engineering or related field with minimum 4 years of relevant experience OR Master's with internship/thesis/industry experience and minimum 3 years of relevant experience.
• Relocation is not provided for this role.
• Candidates should be within a 50-mile radius of Irvine, CA 92618.

Responsibilities

• Contribute to design, development, and advancement of next-generation transcatheter therapies for aortic regurgitation.
• Partner with clinicians, marketing, and cross-functional stakeholders to translate needs into solutions.
• Develop and execute engineering studies, verification activities, and test methods.

Skills

Design verification

Data analysis

Cross-functional collaboration

Technical documentation

Problem-solving

Education

Bachelor's degree in Engineering

Master's degree in Engineering

Tools

SolidWorks

Creo

MS 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 and be part of our inspiring journey. Join us and help shape the future of cardiovascular care.

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, Biomedical Engineering, Mechanical Engineering, Materials Engineering, or a related scientific field and a minimum of 4 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 and a minimum of 3 years of relevant engineering experience Relocation is not provided for this role.
• Only candidates within a 50-mile radius of 1 Edwards, Irvine CA 92618 will be considered.

What Else We Look For (Preferred)

Experience supporting medical device, biotechnology, healthcare, or other highly regulated product development environments. 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, the base pay range for this position is $108,000 - $153,000 (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.