R&D Engineer – Catheter Systems (Medical Devices)

Actalent; Charlotte (NC); Presencial; USD 53.000 - 99.000; Jornada completa

Descripción de la vacante

Actalent is seeking a Medical Device Engineer in Charlotte, NC to design and develop complex catheter-based devices. The candidate will work across the full product lifecycle from concept to commercialization, emphasizing hands-on prototyping, design controls, and manufacturing understanding.

The role requires experience in catheter systems, materials, and multi-material constructions, with a strong background in 3D CAD using SolidWorks.

Formación

• Minimum of 3 years of medical device product development experience; 5+ years preferred.
• Deep knowledge of catheter design, materials, and manufacturing processes.
• Hands-on prototyping capability and experience with design control and risk management.

Responsabilidades

• Lead or participate in the design and development of complex catheter-based devices and delivery systems.
• Translate product requirements into functional engineering solutions and 3D CAD models.
• Create detailed drawings, assemblies, and specifications in SolidWorks or similar CAD tools.
• Perform engineering analysis including tolerances, material selection, and testing.
• Support design verification, DV planning, test method development, and protocol execution.
• Collaborate with Operations, Tooling, Quality, and Manufacturing to develop scalable processes.
• Contribute to DFMA initiatives for catheter assembly, braiding, bonding, thermoforming, and other processes.
• Maintain DHF documentation and manage design inputs/outputs and risk files.
• Translate clinical requirements into engineering inputs and conduct design reviews.

Conocimientos

Biomedical engineering

Mechanical engineering

Catheter design

3D CAD

Prototyping

Design controls

ISO 5840

FDA regulations

Troubleshooting

Cross-functional collaboration

Educación

Bachelors in Biomedical/Mechanical Eng

Herramientas

SolidWorks

Descripción del empleo

Actalent is seeking a Medical Device Engineer in Charlotte, NC to design and develop complex catheter-based devices. The candidate will work across the full product lifecycle from concept to commercialization, emphasizing hands-on prototyping, design controls, and manufacturing understanding.

The role requires experience in catheter systems, materials, and multi-material constructions, with a strong background in 3D CAD using SolidWorks.