Edwards Lifesciences’ Advanced Technology division is passionate about developing solutions for patients suffering from structural heart disease. We are seeking a talented and agile engineering professional to join this fast-paced, dynamic team to play a central role in the development of new therapies. The individual who fills this role will play a pivotal role in the design, development and testing of catheters and sheaths from concept to early clinical feasibility and commercialization.

Join us to incubate and explore world-class innovations in Structural Heart Disease to substantially improve patient outcomes!

This role is based on-site at Edwards’ corporate headquarters in Irvine, California.

How you’ll make an impact: Provide R&D engineering leadership to drive the development activities to launch associated accessories with next gen novel delivery systemsLead in the improvement, design and optimization of more complex experiments, tests, be able to analyze results and provide complex recommendations based on engineering principles that translate to innovative productsOversee R&D support tasks; give instruction to technicians/engineers on conducting tests; train technicians/engineers and provide feedback; and coordinate technician/engineer work.Proactively identify issues, achieve resolution, and resolve problems of significant complexity on designing parts, components and subsystemsGenerate work instructions, test methods, engineering models and drawings/prototypes, etc., to establish/characterize product and/or process specificationsCreate/update complex design control documents including requirement specs, and risk documents with robust knowledge on design control requirementsDevelop project plans to assess technology and drive project resultsTrain, coach, and guide lower level employees on more complex proceduresSupport supplier development activitiesSupport clinical development and possibly clinical field activityOther incidental duties

What you'll need (Required):
Bachelor's Degree in Engineering or Scientific field and 6+ years of experience, including either industry or industry/education - OR
Master's Degree in Engineering or Scientific field and 5+s years experience, including either industry or industry/education - OR
Ph.D. in Engineering or Scientific field and 2+ years of experience, including either industry or industry/education
What else we look for (Preferred):
• Previous Class III medical device experience• Ability to comprehend ISO 13485 design control requirements• Experience in complex mechanical delivery systems• Knowledge and understanding of design control, with emphasis on design verification/validation• Preferred Black Belt Certification and/or proficient statistical skills
• Proficiency in the usage of relevant computer software (CAD, solidworks)
• Proficiency in lab equipment and test methods such as Instron/tensile testing, simulated clinical use, etc.
• Clinical aptitude is strongly preferred
• Excellent documentation and technical presentation/communication skills
• Excellent interpersonal relationship skills including negotiating and relationship management skills
• Extensive knowledge and understanding of principles, theories, and concepts relevant to Engineering
• Advanced problem-solving, organizational, analytical and critical thinking skills
• Extensive understanding of processes and equipment used in assigned work
• Strict attention to detail
• Ability to interact professionally with all organizational levels
• Ability to manage competing priorities in a fast paced environment
• Must be able to work in a team environment, including frequent inter-organizational and outside customer contacts
• Represents organization in providing solutions to difficult technical issues associated with specific projects

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 [choose one: California (CA), the base pay range for this position is $118,000 to $167,000 (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.

COVID Vaccination Requirement

Edwards is committed to protecting our vulnerable patients and the healthcare providers who are treating them. As such, all patient-facing and in-hospital positions require COVID-19 vaccination. If hired into a covered role, as a condition of employment, you will be required to submit proof that you have been vaccinated for COVID-19, unless you request and are granted a medical or religious accommodation for exemption from the vaccination requirement. This vaccination requirement does not apply in locations where it is prohibited by law to impose vaccination.