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.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.We are seeking an exceptional Senior Principal Engineer to serve as a Technical Operations Integrator for our THV R&D Implant Development Team. This team is dedicated to innovating and developing best-in-class valves to fulfill the mission of the THV R&D group. As a key partner with the Global Supply Chain & Operations group, the Senior Principal Engineer will concentrate on pre-commercial R&D manufacturing and process development.How you’ll make an impact:
Initiate and lead a NPD team to design and develop a new generation transcatheter valve and its manufacturing process following the design control process.
Lead a team to optimize the manufacturing process, conduct tests, analyze results and come up with innovative and engineering-based solutions to problems.
Generate work instructions, test methods, engineering models and drawings/prototypes, etc., to establish/characterize product and/or process specification
Oversee R&D support tasks; give instruction to technicians/engineers on conducting tests; train technicians/engineers and provide feedback; and coordinate technician/engineer work.
Interface with cross functional team including Manufacturing, Quality, Regulatory Affairs, Marketing, vendors/suppliers, to ensure compliance with internal design control procedures and external policies and procedures (QSR, FDA & ISO Regulations, and Industry Standards).
Partner with Global Supply Chain at the Pilot and Commercial manufacturing site for successful transfer and release of Clinical and Commercial device.
Create engineering models and drawings, lead prototype & DV builds
Proactively identify issues, achieve resolution, and resolve problems of highly significant complexity on designing parts, components and subsystems
Train, coach, and guide lower-level employees on more complex procedures
Other incidental duties
What you'll need (Required):
Bachelor’s degree in engineering or Scientific field, 8+ years of experience, including either industry or industry/education – OR –
Master’s degree in engineering or Scientific field, 7+ years of experience, including either industry or industry/education – OR –
Ph.D. in Engineering or Scientific field, 4+ years of experience, including either industry or industry/education
What else we look for (Preferred):
Proficient in good manufacturing practices, design control processes, and quality systems.
Experienced in collaborating with production operators and personnel.
Skilled in installation, operational, and process validations.
Adept at transferring new technologies, tooling, and products to pilot or production environments.
Utilizes engineering data-driven methodologies and statistical tools for problem-solving and decision-making.
Training in statistics and Six Sigma is advantageous.
Knowledge of fixturing design and bioprosthetic valve design (including tissue, textile components, metals, assembly methodology, valve processing, packaging, and sterilization) is preferred but not mandatory.
Strong leadership capabilities.
Possesses a can-do attitude, works with urgency, and thrives in dynamic, fast-paced environments.
Effective in verbal and written communication, listening, and diagnostic skills, with the ability to present technical materials and project updates to leadership.
Demonstrates effective collaboration and influencing skills to achieve results within cross-functional teams and with stakeholders.
Highly motivated, driven, and capable of tackling challenging technical problems independently with minimal supervision.
Exhibits a sense of ownership and accountability for project outcomes.
Able to manage competing priorities in a fast-paced environment.
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 $136,000 to $192,000 (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 RequirementEdwards 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.
