Engineer II, THV R&D

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

Job summary

Edwards Lifesciences in Irvine, CA seeks an R&D Engineer to drive design, characterization and verification of a next-generation sheath platform. You will work across product concept to commercialization with teams in Quality and Manufacturing to meet clinical milestones.

The role requires a Bachelor’s or Master’s in Engineering/Science and 2+ years in medical devices, with relocation not provided. California base pay ranges from $87,000 to $123,000 and depends on qualifications.

Qualifications

• Bachelor’s degree in Engineering or Scientific field with 2 years of experience, or Master’s degree/senior project/internship in Engineering or Science.
• Relocation not provided; candidates within a 50-mile radius of Irvine, CA will be considered.
• 2+ years medical device industry experience preferred.

Responsibilities

• Design, characterization, and verification of a new sheath platform.
• Support the full development cycle from concept through commercialization with cross-functional teams.
• Create and refine engineering drawings, component specifications, prototypes, and design documentation.
• Collaborate with suppliers to define specifications and tolerances and establish acceptance criteria.
• Provide technical guidance to laboratory technicians, including test execution and coordination of activities.
• Author and update design control documentation, including risk management files, protocols, reports, and specifications.

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.

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:

This role will participate in and drive aspects of the design, characterization, and verification of this new sheath platform. This role will provide support throughout the full development cycle from product concept through commercialization; working with a cross-functional team to achieve both clinical and commercial milestones.

• Contribute to the design, development, and advancement of next-generation expandable sheath technology.

• 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.

• Partner with cross-functional stakeholders to translate physician and patient needs into innovative product solutions.

• 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.

• Provide technical guidance to laboratory technicians, including test execution, training, and coordination of assigned activities.

What you’ll need (Required):

• Bachelor’s degree in an Engineering or Scientific field with 2 years of experience; or

• Master’s degree or equivalent in an Engineering or Scientific field, with an internship, senior project, or thesis in an Engineering or Scientific field, including industry or combined industry/education experience.

• Relocation is not provided for this role.Only candidates within a 50-mile radius of Irvine, CA will be considered

What else we look for (Preferred):

• 2+ years medical device industry experience

• Degree in Mechanical, Biomedical, Materials or Chemical Engineering

• Experience designing and executing engineering experiments, analyzing data, and drawing data-driven conclusions.

• Knowledge of statistical analysis techniques and engineering problem-solving methodologies.

• Familiarity with product development processes, including design controls, risk management, verification, and validation.

• Experience developing engineering drawings, specifications, and test methods.

• Experience working with suppliers or external partners to develop components or processes.

• Experience with CAD software such as SolidWorks, Creo, or an equivalent platform.

• Strong technical documentation, communication, analytical, and critical-thinking skills.

• Ability to manage competing priorities and work effectively in a fast-paced, cross-functional environment.

• Strong attention to detail and commitment to quality.

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 $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.