Senior Medical Device R&D Engineer - FEA & THV Systems

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

Benefits offered by this job

Competitive salary

Performance-based incentives

Benefits package

Job summary

Edwards is seeking an experienced medical device engineer to apply Finite Element Analysis to heart valve systems and associated delivery devices. You will work with Clinical Development and R&D to develop accurate boundary conditions and robust FEA models for THV components.

The role requires strong experience in simulation (ANSYS/ABAQUS), bench testing, and documentation, with knowledge of ISO/FDA guidelines.

Qualifications

• Bachelor’s degree in engineering or related field with 4+ years of experience, or Master’s with 3+ years.
• Experience in Finite Element Analysis and device development is required.
• Proficiency with ANSYS or ABAQUS for complex biomechanical simulations.

Responsibilities

• Develop FEA models for THV frames, access and delivery systems.
• Collaborate with Clinical Development and R&D to set boundary conditions.
• Lead test method development and virtual/bench testing.
• Document results and generate technical reports.
• Ensure compliance with QSR and FDA regulations.
• Support sustaining engineering as needed.

Skills

FEA

ANSYS

ABAQUS

MATLAB

Minitab

Statistical analysis

Cardiovascular knowledge

FDA submissions

Documentation

Bench fixtures

Education

Bachelor's degree in engineering or related field

Master's degree in engineering or scientific field

PhD in engineering (preferred)

Tools

Materialise

Simpleware

Job description

Edwards is seeking an experienced medical device engineer to apply Finite Element Analysis to heart valve systems and associated delivery devices. You will work with Clinical Development and R&D to develop accurate boundary conditions and robust FEA models for THV components.

The role requires strong experience in simulation (ANSYS/ABAQUS), bench testing, and documentation, with knowledge of ISO/FDA guidelines.