Senior Medical Device Engineer – NPD & Manufacturing

Edwards Lifesciences; Irvine (CA); On-site; USD 108,000 - 153,000; Full time

Job summary

Edwards Lifesciences in Irvine, CA, is seeking a Senior Engineer to act as a technical SME, partnering with internal teams and suppliers to ensure devices meet user needs with focus on ease of use, manufacturability, and cost efficiency. This role emphasizes Design Control, Catalyst processes, and timely project execution.

The candidate will lead supplier development, reviews, and technology transfer, while coordinating across R&D, Quality, Operations, and Supply Chain to optimize manufacturing

Qualifications

• Bachelor’s degree in engineering or science with 4+ years in new product development, process development or operations in a regulated setting.
• Willingness to travel up to 25% domestically and internationally.
• On-site work is required.

Responsibilities

• Lead commercialization of next-gen medical devices with supplier development, validation, and manufacturing integration from concept to launch.
• Collaborate with R&D, Quality, Operations, Supply Chain and suppliers to translate designs into scalable manufacturing solutions.
• Incorporate DFM, manufacturability, quality, reliability and cost considerations early in development.
• Provide guidance through design reviews, risk assessments, and process capability evaluations to ensure robust manufacturing outcomes.
• Define supplier qualification/validation strategies for OEMs and contract manufacturers.

Skills

Engineering leadership

Cross-functional collaboration

Regulated environment

DFM knowledge

Education

Bachelor's degree in engineering

Master's degree in engineering and/or MBA

Tools

GD&T

Six Sigma

Job description

Edwards Lifesciences in Irvine, CA, is seeking a Senior Engineer to act as a technical SME, partnering with internal teams and suppliers to ensure devices meet user needs with focus on ease of use, manufacturability, and cost efficiency. This role emphasizes Design Control, Catalyst processes, and timely project execution.

The candidate will lead supplier development, reviews, and technology transfer, while coordinating across R&D, Quality, Operations, and Supply Chain to optimize manufacturing