Senior Engineer, Supplier Development (MedTech)

Edwards Lifesciences; Irvine, Northern (CA, KY); Hybrid; USD 108,000 - 153,000; Full time

Job summary

Edwards Lifesciences in Irvine, CA, seeks a Senior Engineer for the Transcatheter Mitral and Tricuspid Therapies (TMTT) unit to lead design-to-manufacturing efforts from concept through product launch. The role partners with R&D, Quality, Operations, and Supply Chain to ensure manufacturability, reliability, and cost optimization while applying Design Control and Catalyst processes.

The position requires a strong background in medical device development, with at least 4 years in NPD and process

Qualifications

• Bachelor's degree in engineering or scientific field with 4 years of experience in new product development, process development, commercialization, and/or operations engineering in a highly regulated environment.
• Travel up to 25% domestically and internationally.
• On-site work required.

Responsibilities

• Lead the successful commercialization of next-generation medical devices by driving supplier development and manufacturing integration from concept through product launch.
• Serve as a key technical leader in NPD, partnering with R&D, Quality, Operations, Supply Chain and suppliers to translate designs into scalable manufacturing solutions.
• Ensure DFM considerations are incorporated to achieve manufacturability, quality, reliability, and cost optimization.
• Drive collaboration with strategic suppliers to develop advanced manufacturing processes and assess new technologies.
• Provide engineering guidance through design reviews, risk assessments, and process capability evaluations.
• Define supplier qualification and validation strategies for OEMs, contract manufacturers, and critical components.
• Lead technical governance with suppliers to align on objectives and resolve challenges.
• Develop innovative manufacturing technologies and production strategies to support new products and faster commercialization.
• Conduct supplier assessments focusing on capability, quality systems, capacity, and scalability.
• Partner with suppliers and internal teams to optimize processes, implement automation, improve yield and drive continuous improvement.
• Champion technology transfers and design-to-manufacturing transitions for readiness and performance across global sites.
• Lead supplier risk management and capacity planning to support uninterrupted supply and launches.
• Provide updates during supplier audits, investigations, regulatory submissions, design changes, and post-market enhancements.

Skills

New product development

Process development

Commercialization

Operations engineering

Education

Bachelor's degree in engineering or science

Master’s degree in engineering and/or MBA

Job description

Edwards Lifesciences in Irvine, CA, seeks a Senior Engineer for the Transcatheter Mitral and Tricuspid Therapies (TMTT) unit to lead design-to-manufacturing efforts from concept through product launch. The role partners with R&D, Quality, Operations, and Supply Chain to ensure manufacturability, reliability, and cost optimization while applying Design Control and Catalyst processes.

The position requires a strong background in medical device development, with at least 4 years in NPD and process