Senior Principal Engineer, R&D - Access Technology

Edwards Lifesciences; Irvine (CA); On-site; USD 139,000 - 196,000; Full time

Job summary

Edwards Lifesciences in Irvine, CA is seeking a Senior Principal Engineer, R&D to lead the design and development of next-generation access technologies from concept to commercialization, working with Quality and Manufacturing to address unmet clinical needs and improve patient outcomes.

This role partners with cross-functional teams to drive manufacturing transfer, verification testing, and robust design strategies, while mentoring engineers and advancing technical excellence across the Access

Qualifications

• Bachelor's degree with 8+ years of related experience
• Master's degree with 7+ years of related experience
• Minimum of 5 years of medical device product and/or process development experience

Responsibilities

• Drive the technical development of a next-generation expandable sheath, including Design for Manufacturing considerations, through all phases of the Design Control process while serving as the technical subject matter expert.
• Lead the development of product and component specifications.
• Develop and execute design verification strategies and testing plans, including biocompatibility activities.
• Represent the Access R&D team with internal technical partners and senior business leadership.
• Develop and implement long‑term strategies for deploying innovative design solutions within the Access platform.
• Partner with Process Development and Manufacturing teams to transfer new designs into commercial production.
• Guide and mentor engineers in solving complex technical challenges.
• Promote technical excellence and knowledge sharing across teams and functions.

Skills

Design for Manufacturing

Design verification

3D modeling

Cross-functional collaboration

Technical leadership

Education

Bachelor's degree in Engineering or related field

Master's degree in Engineering or related field

Tools

CAD software

Job description

Edwards Lifesciences in Irvine, CA is seeking a Senior Principal Engineer, R&D to lead the design and development of next-generation access technologies from concept to commercialization, working with Quality and Manufacturing to address unmet clinical needs and improve patient outcomes.

This role partners with cross-functional teams to drive manufacturing transfer, verification testing, and robust design strategies, while mentoring engineers and advancing technical excellence across the Access