Job Information
Edwards Lifesciences Principal Engineer, New Product Development in Irvine, California
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.
The THV Balloon Expandable Delivery System New Product Development (NPD) team is looking for a Principal Engineer to support the development of our next-generation balloon expandable delivery systems. The Principal Engineer will have the opportunity to drive process design and characterization, work on a strong cross-functional team, and partner with the commercial site on process validations and commercialization activities.
How you will make an impact:
Drive process development and characterization for Commercial device releases using DMAIC methodologies which involves the execution of complex experiments and tests (including writing and executing protocols), analyzing results, making recommendations, and developing reports.
Serve as a main interface between R&D, Pilot, and commercial manufacturing.
Create user requirement specifications for process equipment.
Design tooling and fixtures.
Develop process validation strategies and participate in validation execution in conjunction with the commercial manufacturing site.
Drive process DFM, process FMEAs, and mistake proofing analysis and implementation.
Collaborate on test method development.
Participate in product design and specification development.
Partner with Operations and Supply Chain at the Pilot or Commercial manufacturing site for successful.
What you’ll need (Required)
Bachelor's Degree in in Engineering or Scientific field with 6 years of experience in manufacturing operations and/or NPD.
Medical device experience.
What else we look for (Preferred)
Experience with UV curing and adhesive bonding processes.
Expert knowledge of design controls for Class III medical devices, including familiarity with Steerable Catheter and Delivery Systems.
Technical understanding and experience in manufacturing engineering:
cGMP and EH&S
Process Development
Design for manufacturability (DFM)
Process excellence methodologies including Six Sigma, and LEAN
Supplier development
Excellent written and verbal communication skills and interpersonal relationship skills including negotiating and relationship management skills with ability to drive achievement of objectives.
Expert understanding of critical to quality (CTQ) design elements and cascading CTQs to design inputs / outputs and establishing process controls / limits.
Experience with development through commercialization process of medical devices.
Proven successful project management leadership skills.
Ability to influence cross-functional partners, business units, and/or sites and may engage with and influence senior management.
Ability to lead briefings and technical meetings for internal and external representatives.
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 $115,000 to $163,000 (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 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.
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 15,000 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.