Senior Delivery Systems Engineer – Transcatheter Devices

HighLife; Irvine (CA); On-site; USD 140,000 - 190,000; Full time

Job summary

HighLife Medical seeks a Principal R&D Engineer to lead the design and development of transcatheter delivery systems. You will work cross-functionally with clinical, manufacturing, and regulatory teams to bring robust delivery-system technologies from concept through commercialization.

The role emphasizes hands-on mechanical design, rapid prototyping, and DFMA principles in a fast-paced medical-device environment. Strong CAD skills and device-delivery expertise are essential.

Qualifications

• Bachelor's or Master's in engineering with medical device development experience.
• Experience with catheter-based delivery systems and transcatheter devices.
• Experience taking devices through concept to design transfer and verification.
• Hands-on mechanical design and prototyping capabilities.
• Familiarity with FDA-regulated / ISO 13485 environments.

Responsibilities

• Serve as technical leader for design and development of transcatheter delivery systems.
• Lead development activities from concepts through commercialization.
• Translate clinical needs into engineering specifications and solutions.
• Develop catheter-based solutions addressing delivery, navigation, deployment, and system integrity.

Skills

Catheter design

Mechanical design

Prototype development

Design for Manufacturing

FDA/ISO 13485 experience

CAD (SolidWorks)

Leadership

Root-cause analysis

Cross-functional collaboration

Education

Bachelor's in Mechanical/Biomedical Engineering

MS in related engineering

Tools

SolidWorks

Job description

HighLife Medical seeks a Principal R&D Engineer to lead the design and development of transcatheter delivery systems. You will work cross-functionally with clinical, manufacturing, and regulatory teams to bring robust delivery-system technologies from concept through commercialization.

The role emphasizes hands-on mechanical design, rapid prototyping, and DFMA principles in a fast-paced medical-device environment. Strong CAD skills and device-delivery expertise are essential.