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 looking for an exceptional Senior Engineer to join the THV R&D valve manufacturing development team, specifically working on a first of its kind Aortic Regurgitation solution. This group lives the Edwards Lifesciences mission daily, revolutionizing patient care and transforming medicine by innovating breakthrough medical technologies. This role will require an innovative mindset, focused on fixture development, process development, and design for manufacturability

How you’ll make an impact:

• Drive results for the team technical integrator (each project team has a technical integrator that serves as the leader of a group of engineers supporting the common project)

• Generate design and process documentation for upcoming R&D and Design Verification (DV) builds

• Support needs of the sewers/operators and pilot line for R&D and DV builds, with ability to organize and manage complex build schedules with numerous stakeholders.

• Computer aided design (CAD) work on next fixtures and tools to ensure more effective and efficient sewing and manufacturing, reducing touch time to meet goals.

• Partner with Global Supply Chain and Suppliers to develop process flows for incoming parts and materials, ensuring they meet Edwards standards.

• Guide and implement validation strategies for the program to meet development project milestones as well as long-term product platform goals.  Includes authoring and executing validation plans, protocols & reports.    

• Explore and implement new process technology to drive design for manufacturability (DFM) and deliver new product performance for patients

• Interface with cross functional team including Manufacturing, R&D, Quality, Regulatory Affairs, Marketing, vendors/suppliers, to ensure alignment, progress, and compliance with design control procedures (QSR, FDA Regulations, and ISO Standards)

What you'll need (Required):

• Bachelor's Degree in Engineering

• 4+ years of experience in a regulated industry including: new product development & product transfer or production support

What else we look for (Preferred):

• Medical Device experience is preferred; medical device manufacturing experience is highly preferred.

• Bachelor’s Degree in Mechanical, Manufacturing or Biomedical Engineering is highly preferred.

• A can-do attitude, work with urgency and enjoy working in a dynamic and fast paced environment.

• High motivation, drive, and the ability to tackle challenging technical problems independently with minimal supervision.

• Highly organized with strong ability to communicate data and decisions.

• Understand statistical tools and their use in engineering problem solving & decision making.  Six Sigma training.

• Experience validating test methods, equipment and processes.

• Computer aided design (CAD) experience.

• Able to lead and manage engineering and new implementation projects

• Understanding of bioprosthetic valve design (tissue, textile components, metals, assembly methodology, valve processing, packaging, EO & Ebeam sterilization).

• Effective communication, listening, and diagnostic skills, verbal and written, are necessary.

• The demonstration of effective collaboration and influencing skills will be key so that the candidate can achieve results within the cross functional team and with stakeholders around the company.

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 $106,000 to $149,000 (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.