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. 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.
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.
How you will make an impact:
This is a rare opportunity to join a fast-paced, passionate Delivery System R&D team, within Edwards Lifesciences’ Transcatheter Mitral and Tricuspid Therapies group, working on transcatheter replacement therapies to address Tricuspid disease.
This team is deeply dedicated to transforming treatment to significantly improve patient lives around the world through valve replacement and we need your talent!
This Engineer II role will support the next-generation system qualification and commercialization for a product line that offers a novel, highly efficacious therapy to a broad group of patients in need. With your help, this next-generation team will enable the continued growth of an innovative platform that supports a growing transcatheter tricuspid replacement therapy.
Build and evaluate products by developing complex experiments and tests (including writing and executing protocols), analyze results, make recommendations, and develop reports, based on engineering principles
Evaluate manufacturing and clinical inputs, form technical recommendations, and help influence the design of future device iterations
Identify, evaluate, manage, and provide guidance to suppliers, including establishing tolerances and defining acceptance criteria for suppliers
Generate test methods, engineering models and drawings/prototypes, etc., to characterize product and/or process specifications
Assign R&D support tasks; give instruction to technicians on conducting tests; train technicians and provide feedback
Create/update sophisticated design control documents
Other duties assigned by Leadership
What you'll need (Required):
Bachelor's Degree in Engineering or Scientific field with 2+ years of experience -OR- Master's Degree or equivalent in Engineering or Scientific field with internship, senior projects, or thesis in Engineering or Scientific field including either industry or industry/education
What else we look for (Preferred):
Mechanical Engineering degree strongly preferred
Substantial understanding and knowledge of principles, theories, and concepts relevant to Engineering design, design verification & validation
Catheter Manufacturing processing experience
Medical device design & development experience
Experience with DV&V, OQ/PQ
Test method validation experience
Experience with statistical techniques
CAD experience
Knowledge of and adherence to Edwards Environmental Health and Safety and Quality guidelines as they relate to department clean room medical device manufacturing
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 the ability to manage vendors and project stakeholders
Ability to build productive internal/external working relationships
Adhere to all company rules and requirements (e.g., pandemic protocols, Environmental Health & Safety rules) and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of influence/control
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 $85,000 to $120,000 in tool (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.