Lead Systems Engineer in Medical R&D

Make a difference in patient lives with Edwards as a Lead Systems Engineer in Irvine, CA. Focus on innovative R&D for structural heart disease solutions while ensuring regulatory compliance.

In this on-site role, you will join our talented R&D team dedicated to addressing significant clinical needs with pioneering technologies. Your responsibilities will include the design and development of the Cordella platform, requiring close collaboration with Quality and Manufacturing teams to ensure product performance and safety. Your expertise in risk management and product documentation will be pivotal for our mission.

Key Responsibilities:

• Lead development of engineering project plans and reports

• Generate engineering models and specifications

• Conduct user research for effective design decisions

• Ensure regulatory compliance throughout product lifecycle

• Drive strategic solutions in design and development

Requirements:

• Ph.D. or equivalent in engineering or science

• Experience with FDA regulations and ISO 13485

• Background in design controls and risk management

• Skills in data analysis and script development

• Strong organizational and interpersonal skills

Help redefine what's possible in medical technology with your engineering skills at Edwards.
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