Engineer I, NPD
Edwards Lifesciences
Irvine, California
Full-Time
$69,000
OfficeExecutive
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 New Product Development Engineering team, you will work closely with our R&D and Quality teams to develop the latest tools and technologies to address significant, unmet clinical needs that impact patients’ lives around the world.
Aortic stenosis impacts millions of people globally, yet it often remains under-diagnosed and under-treated. Edwards’ groundbreaking work in transcatheter aortic heart valve replacement (TAVR) pioneered an innovative, life-changing solution for patients by offering heart valve replacement without the need for open heart surgery. Our Transcatheter Heart Valve (THV) business unit continues to partner with cardiologists and clinical teams to transform patient care with devices supported by clinical evidence. It’s our driving force to help patients live longer and healthier lives. Join us and be part of our inspiring journey.
How you'll make an impact:
Support design control activities for manufacturing product and process development
Develop manufacturing documentation (drawings, SOPs, routers, pFMEA) across various release stages and create training materials to enable seamless knowledge transfer to production
Support process definition and development of process controls
Provide operations input into specifications (DFx, tolerancing, material selection, automation), supporting stability metrics and risk mitigation through SCRR and MRR
Collaborate on build strategy, prioritization, and technical support for QST, pre-DV, and DV; partner with Pilot on root cause investigations prior to commercialization
Support development and execution of experiments and test protocols to characterize and refine processes; assist with qualifications and validations (IQ, OQ, software)
Support manufacturing equipment engineering and tooling design for program-specific needs
Assist in analysis of manufacturing and compliance issues (CAPA, non-conformances, audit observations) and support process transfer activities
Identify opportunities to redesign equipment, tools, and fixtures to improve manufacturing processes
Drive continuous improvement using engineering methods (LEAN, basic statistics)
Perform other duties as assigned by leadership
What you’ll need (Required):
Bachelor's Degree in Engineering or Scientific field
What else we look for (Preferred)
Demonstrate strong proficiency in MS Office Suite (including MS Project); CAD experience preferred, if applicable
Apply clear written and verbal communication skills with strong interpersonal effectiveness
Demonstrate a basic understanding of statistical techniques
Show experience working with lab or industrial equipment, if applicable
Apply foundational engineering principles, theories, and concepts
Solve problems effectively using strong organizational, analytical, and critical thinking skills
Demonstrate understanding of processes and equipment relevant to assigned work
Adhere to Edwards Environmental Health & Safety and Quality guidelines, including clean room medical device manufacturing standards
Maintain strict attention to detail
Interact professionally across all organizational levels
Manage competing priorities effectively in a fast-paced environment
Collaborate effectively in a team environment, including working with supervisors, cross-functional teams, and external vendors
Build and maintain stable internal 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, the base pay range for this position is $69,000 to $98,000 (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.