Edwards Lifesciences

Director, Supplier Development Engineering

USA - California – Irvine Full time

Innovation starts from the heart. Edwards Lifesciences is the leading global structural heart innovation company, driven by a passion to improve patient lives. With millions of patients served in over 100 countries, each team makes a meaningful contribution by improving patient outcomes and discovering lasting solutions for unmet patient needs. Our Director, R&D Supplier Development Engineering, position is a unique career opportunity that could be your next step towards an exciting future.

How you will make an impact:

• Partner with R&D leaders in the design and development of the delivery system products and be accountable for achieving new and generational improvements of this transcatheter replacement therapy.

• Hands-on leader with sound technical knowledge, strong leadership skills, and the ability to guide and develop a highly driven and technical team.

• Lead the team responsible for design and development with suppliers, development and testing of complex interventional catheters for delivery of implantable devices with suppliers.

• Demonstrates focus on staff development, ethics and motivation through appropriate assignment of opportunities and training activities to support the achievement of both professional development goals and business goals.

• Actively engage in development of staff performance management objectives (PMOs), ensuring deliverables are met on time.

• Manage and drive timelines for feasibility testing activities, design verification testing, clinical trials and supplier validations for commercial release testing.

• Build and maintain strong relationships with R&D, Suppliers, Program Management, Manufacturing, and Supplier Quality to ensure successful project execution and compliance with internal and policies and procedures (QSR, FDA Regulations, and ISO Standards).

• Partner and support product development efforts in the design and iteration of new delivery systems, and components for transcatheter tricuspid valve replacement technologies.

What you’ll need (required):

• Bachelor's degree in a related field (Engineering, Applied Sciences, Etc.) and experience in engineering

• Demonstrated track record in management of technical and/or engineering disciplines.

What else we look for (preferred):

• Master's degree OR PHD in engineering (Mechanical or Biomedical).

• Medical Device experience in new product development with successful design optimization from development to commercialization.

• Experience managing engineering teams and cross-functional relationships.

• Experience managing external vendors.

• Experience with rapid product development in cross-functional teams, creative design, prototyping, and test method development (in-vitro-testing).

• Proven ability to apply technical knowledge and judgment to complex engineering problems. Knowledge of DFM, GD&T and Six Sigma methodology.

• Skills in biomechanical design and Delivery System catheter design.

• Experience in catheter and related manufacturing (extrusions, braiding, molding, laser-cutting and bonding processes).

• Strong interpersonal and people management skills. High emotional intelligence.

• Displays broad perspective and effective judgment, demonstrates well-reasoned problem solving and decision-making. Ability to be bold and decisive to drive action.

• Builds a shared vision; inspires others to action; sets clear direction; establishes plans consistent with that direction.

• Demonstrates a sense of urgency; understands the importance of outperforming and outpacing the competition in meeting customer and patient needs.

• Ability to work in a matrix organization and lead cross functional teams.

• Able to demonstrate strong skills as an innovator, problem solver, and mentor.

• Strong problem solving and root cause analysis skillset and the ability to rapidly iterate and react to clinical device feedback.

• Preferred background includes experience in more than one of the following areas: Interventional access devices, rapid product development and manufacturing of components and complex assembly design.

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 $156,000 to $221,000 (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.