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.

Patients with mitral and tricuspid heart valve disease often have complex conditions with limited treatment options. Our Transcatheter Mitral and Tricuspid Therapies (TMTT) business unit is boldly pursuing an innovative portfolio of technologies to address a patient’s unmet clinical needs. It’s our driving force to help patients live longer and healthier lives. Join us and be part of our inspiring journey.

We are looking for a Senior Engineer who will apply knowledge of technical principles and Edwards systems/procedures to optimize, maintain, and develop the SAPIEN M3 commercial platform. The SAPIEN M3 is a transcatheter mitral valve replacement (TMVR) system developed by Edwards Lifesciences. It is designed to treat mitral regurgitation (MR) in patients deemed unsuitable for surgery or transcatheter edge-to-edge repair (TEER). The system utilizes a two-stage approach: a nitinol "dock" that anchors around the native mitral valve and a balloon-expandable SAPIEN 3 valve adapted for the mitral position. It is the world’s first approved transfemoral TMVR system. 
 
How you’ll make an impact:

Work in a cross-functional environment (Quality, Manufacturing, Clinical, and Regulatory) for change implementation, complaint handling, and device evaluation.

Improve products by developing complex experiments and tests (including writing and executing protocols), analyzing results, and making recommendations based on engineering principles 

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

Create/update 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 with 4+ years of experience in the medical device industry – OR -

Master’s degree in Engineering or Scientific field with 3+ years of experience in the medical device industry 

What else we look for (preferred):

 Substantial understanding and knowledge of principles, theories, and concepts relevant to Engineering.   

Knowledge of materials and processes for shaft construction, injection molding is a plus. 

Basic understanding of clinical imaging, procedural workflows.  

Knowledge of and adherence to Edwards Environmental Health and Safety and Quality guidelines as they relate to department clean room medical device manufacturing  

Strong documentation, communication (e.g., written and verbal) and interpersonal relationship skills including consultative and relationship management skills  

Proven expertise in usage of MS Office Suite; CAD experience preferred 

Basic understanding of statistical techniques 

Previous experience working with lab/industrial equipment required (if applicable) 

Good leadership skills and ability to influence change 

Ability to manage competing priorities in a fast-paced environment 

Must be able to work in a team environment, including inter-departmental teams and key contact representing the organization on contracts or 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 $106,000 to $149,000 (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.