Job description

We’re looking for engineers with HEART . At Edwards Transcatheter Mitral and Tricuspid Therapies (TMTT), we are guided by our vision to lead and transform treatment for patients with mitral and tricuspid heart valve disease.

True to our patients-first focus, TMTT’s engineers puts their whole hearts into meeting the needs and improving the lives of this largely underserved patient population. The anatomies and clinical challenges that exist among patients with mitral and tricuspid valve disease are varied and complex, and we are committed to the development of a portfolio of therapies that transforms treatment and provides world-class outcomes.
Our mission is not for the faint of heart, or for those who prefer to go through the motions. As agile-minded trailblazers, our TMTT R&D Engineering team is constantly pivoting and problem-solving to deliver the most effective therapies possible, because it’s not about us or our design ideas, it’s about developing the right solution to meet the needs of the patient.

So, if you’re an exceptional Engineering professional with significant experience and a heart for solving complex challenges, join our team and help us improve patients’ lives through the development of transcatheter mitral and tricuspid therapies from the ground up.

As an integral part of the R&D team, the Senior Engineer will play a pivotal role in an early-stage design and development program through critical commercialization activities for the next-gen of a tricuspid/mitral repair system.

Key Responsibilities:
Design and optimization of a medical device/system for a novel therapy through Early Human Use
Drive design innovation / selection based on patient risk, clinical impact, and supplier / manufacturability
Drive device evaluation and failure mode analysis
Proactively identify issues and resolve problems
Develop test methods and procedures to evaluate device performance
Create complex design control documents (e.g., engineering drawings, DRD, spec. setting technical summaries)
Work closely with physician partners in a pre-clinical environment to develop implanting procedure within accurate phantom test models
Communicate relevant results and findings to team, management, and partnering physicians
Interface with internal (e.g., Manufacturing, Quality , Clinical Development ) and external (e.g. suppliers) partners to ensure compliance governing policies (Edwards Quality Systems, FDA Regulations, ISO Standards)

Education and Experience:
Bachelor's Degree in Engineering + minimum of 4 years of experience OR
Master's Degree in Engineering + minimum of 3 years of experience

Preferred Experience:
Medical Device Experience
Experience with design and development of a class III medical device
Experience with the full R&D product development lifecycle is highly preferred
Experience with design and development of nitinol is a plus
Experience using six sigma blackbelt tools such as DOE and GR&R are highly preferred

Additional Skills:
Proven hands-on and technical aptitude for mechanical design, fabrication, and evaluation
Proficiency in design (experience in CAD or SolidWorks preferred)
Proficiency in medical imaging software
Basic understanding of statistical techniques
Excellent interpersonal relationship skills
Ability to manage competing priorities in a fast-paced environment
Strong design control documentation skills
Advanced problem-solving, organizational, analytical, and critical thinking skills
Adhere to all company rules and requirements (e.g., pandemic protocols, Environmental Health & Safety) and take adequate control measures in preventing injuries to themselves

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 $86 000 to $121 000(highly experienced).
The pay for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience).

About Edwards Lifesciences

Edwards Lifesciences is the global leader in patient-focused medical innovations for structural heart disease, as well as critical care and surgical monitoring. Driven by a passion to help patients, the company collaborates with the world’s leading clinicians and researchers to address unmet healthcare needs, working to improve patient outcomes and enhance lives. Headquartered in Irvine, California, Edwards Lifesciences has extensive operations in North America, Europe, Japan, Latin America and Asia and currently employs over 13,000 individuals worldwide.

For us, helping patients is not a slogan - it’s our life’s work. From developing devices that replace or repair a diseased heart valve to creating new technologies that monitor vital signs in the critical care setting, we focus on helping patients regain and improve the quality of their life.

COVID Vaccination Requirement

Edwards is committed to complying with the requirements and guidance from our government authorities and to protecting our vulnerable patients and the healthcare providers who are treating them around the world. As such, all Healthcare Interacting positions require COVID-19 vaccination, which includes anyone who directly interfaces with patients and those who interact with healthcare providers as part of their role. If hired, as a condition of employment, you will be required to submit proof that you have been fully 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 countries where it is prohibited by law to impose vaccination. In countries where vaccines are less available, or other requirements exist, we may institute alternate measures that optimize patient safety and healthcare provider safety, which may include regular COVID testing or specific masking requirements.

For United States Applicants Only:
Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.
Know your Rights: Workplace Discrimination is Illegal Poster
Disability accommodation for employment applicants
Edwards E-Verify
Family and Medical Leave Act (FMLA)
Employee Polygraph Protection Act (EPPA)
Pay Transparency Notice

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