Engineer II R&D

Edwards Lifesciences Gruppe; United States; On-site; USD 87,000 - 123,000; Full time

Job summary

Edwards Lifesciences invites applications for an Engineer II, R&D focused on next-generation transcatheter therapies for aortic regurgitation. You will work with clinicians and cross-functional teams to translate needs into product solutions and support verification through testing and documentation.

Responsibilities include developing drawings, specifications, and prototypes while collaborating with Manufacturing, Quality, Regulatory, and Operations to advance product development across the

Qualifications

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

Responsibilities

• Contribute to the design, development, and advancement of next-generation transcatheter therapies for AR.
• 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.
• Create and refine engineering drawings, component specifications, prototypes, and design documentation to support milestones.

Skills

Design & development

Data analysis

Documentation

CAD software

Cross-functional collaboration

Testing & verification

Design controls

Education

Bachelor's degree in Engineering

Master's degree in Engineering or related field

Tools

SolidWorks

Creo

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
• 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
• Experience supporting medical device, biotechnology, healthcare, or other highly regulated product development environments.
• Medical device delivery 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).

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.