Director, Supplier Development Engineering

Edwards Lifesciences • Irvine, CA

1d

About The Position

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.

Requirements

• 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.

Nice To Haves

• 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.

Responsibilities

• 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.

Benefits

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Director
• Number of Employees: 5,001-10,000 employees