Lead Engineer – Implantable Heart Failure Systems

Edwards Lifesciences Gruppe; Irvine (CA); On-site; USD 121,000 - 171,000; Full time

Job summary

Edwards Lifesciences in Irvine, CA is seeking a Principal Engineer to lead supplier validation and product development for our Implantable Heart Failure Management (IHFM) team. You will ensure DFMA, quality compliance, and timely project execution in a regulated medical device setting.

You will partner with R&D, Manufacturing, Supplier Quality, and key suppliers to drive design optimization, verification testing, clinical evaluations, and commercialization. Travel up to 25% is required.

Qualifications

• Bachelor's degree in engineering or a scientific field with 6 years in new product development or operations engineering.
• Willingness to travel up to 25% domestically and internationally.
• Experience in regulated medical device development and ISO 13485 quality systems.
• Lean Six Sigma certification or formal training is a plus.
• Strong problem-solving skills and cross-functional collaboration.

Responsibilities

• Lead end-to-end supplier validation and product development activities across design and process characterization.
• Drive design verification testing, clinical evaluations, and supplier validation for commercial release.
• Coordinate with R&D, Program Management, Manufacturing, and suppliers to ensure timely execution.
• Ensure compliance with QSR, FDA regulations, ISO 13485, and risk management practices.
• Oversee feasibility studies, testing timelines, and project milestones for IHFM devices.

Skills

Design Control

Project Management

Supplier Quality

Six Sigma

Cross-functional teamwork

Education

Bachelor's degree in engineering or scientific field

Master’s degree in engineering or MBA

Tools

GD&T

ISO 13485

Process validation

Job description

Edwards Lifesciences in Irvine, CA is seeking a Principal Engineer to lead supplier validation and product development for our Implantable Heart Failure Management (IHFM) team. You will ensure DFMA, quality compliance, and timely project execution in a regulated medical device setting.

You will partner with R&D, Manufacturing, Supplier Quality, and key suppliers to drive design optimization, verification testing, clinical evaluations, and commercialization. Travel up to 25% is required.