Lead Catheter Engineer - Endovascular Robotics & Regulatory

Remedy Robotics; San Francisco (CA); On-site; USD 90,000 - 130,000; Full time

Job summary

Remedy Robotics is seeking an experienced Catheter Engineer to design and develop catheter-based medical devices, ensuring regulatory approval and compliance. The role involves leading product development, managing project timelines and budgets, and coordinating with contract manufacturers.

The ideal candidate has 5+ years of experience, particularly in catheter development, and proven expertise in navigating FDA regulations.

Qualifications

• 5+ years of medical device engineering experience focused on catheter or flexible tubular device development.
• Demonstrated experience with FDA regulatory clearance as the lead engineer.
• Hands-on experience with design history files and validation documentation.

Responsibilities

• Lead design and engineering of steerable catheter products from concept to commercialization.
• Conduct DFM/DFA reviews to ensure manufacturability.
• Coordinate testing programs that meet FDA submission standards.

Skills

Medical device engineering

Catheter development

Regulatory compliance

Cross-functional leadership

Tools

SolidWorks

FDA regulations

ISO 13485

Job description

Remedy Robotics is seeking an experienced Catheter Engineer to design and develop catheter-based medical devices, ensuring regulatory approval and compliance. The role involves leading product development, managing project timelines and budgets, and coordinating with contract manufacturers.

The ideal candidate has 5+ years of experience, particularly in catheter development, and proven expertise in navigating FDA regulations.