R&D Principal Engineer (Irvine)

Structural Heart Disease Engineering Professional

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 systems
• Lead 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 products
• Oversee 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 subsystems
• Generate work instructions, test methods, engineering models and drawings / prototypes, etc., to establish / characterize product and / or process specifications
• Create / update complex design control documents including requirement specs, and risk documents with robust knowledge on design control requirements
• Develop project plans to assess technology and drive project results
• Train, coach, and guide lower level employees on more complex procedures
• Support supplier development activities
• Support clinical development and possibly clinical field activity
• Other 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+ years of 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 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.