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Edwards Lifesciences Senior Engineer, R&D in Irvine, California

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 and critical care. 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.

The SAPIEN M3 Valve Delivery R&D team is looking for a Senior Engineer, R&D who will be responsible for supporting the development of the valve delivery aspects of the SAPIEN M3 platform. SAPIEN M3 is one of Edwards’ transcatheter mitral valve replacement technologies currently concluding a Pivotal study. This Senior Engineer will have the opportunity to work on a strong cross-functional team and support next-generation device design and characterization. This position offers experience in the full development cycle from concept to commercialization.

How you’ll make an impact:

• Create, test, and/or improve products by developing complex experiments and tests (including writing and executing protocols), analyzing results, making recommendations, and developing reports, based on engineering principles

• Generate work instructions, test methods, engineering models and drawings/prototypes, etc., to establish/characterize product and/or process specifications

• Create/update more complex design control documents including requirement specs, and risk documents

• Develop and execute engineering project plans

• Identify, evaluate, manage, and provide guidance to suppliers, including establishing tolerances and defining acceptance criteria for suppliers

• Assign R&D support tasks; give instruction to technicians on conducting tests; train technicians and provide feedback; and coordinate technician work

• Evaluate input and form a technical recommendation including designing parts, components and subsystems

• Train, coach, and guide lower level employees on routine procedures

• Other duties assigned by Leadership

What you’ll need (Required):

• Bachelor's Degree in Engineering or Scientific field, 4+ years experience – OR –

• Master's Degree in Engineering or Scientific field, 3+ years experience – OR-

• Ph.D. in Engineering or Scientific field

What else we look for (Preferred):

• Medical Device development and documentation experience

• Understanding of structural heart anatomy, therapies, and clinical access; specifically mitral

• Balloon catheter experience

• Familiarity with plastics, extrusion, and injection molding

• Ability to interface with outside vendors

• Understanding of statistical techniques

• Basic documentation, communication (e.g., written and verbal) and interpersonal relationship skills

• Previous experience working with lab/industrial equipment

• Good understanding and knowledge of principles, theories, and concepts relevant to Engineering

• Good problem-solving, organizational, analytical, and critical thinking skills

• 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 immediate supervisor and other team members in the section or group

• Ability to build stable working relationships internally

• Good computer skills in usage of MS Office Suite; CAD experience preferred

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 $103,000 to $146,000 (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.

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