Steerabel R&D Engineer (MEDICAL DEVICE)

Aptyx•Charlotte, NC

19d

About The Position

We are seeking a Medical Device Engineer with strong experience in the design and development of complex steerable catheters. This role is intended for candidates at the Engineer II through Senior Engineer level who are comfortable working hands on, driving technical development, and contributing throughout the full product lifecycle.

Requirements

Bachelor's or master's degree in biomedical engineering, mechanical engineering, or a related field.
Three or more years of experience in interventional medical device development, with preference for at least five years of catheter design experience.
Hands on experience with steerable or deflectable catheter architectures.
Strong understanding of catheter materials including hypotubes, nitinol, polymer shafts, braids, coils, and bonding processes.
Proficiency with 3D CAD, preferably SolidWorks.
Demonstrated ability to build prototypes, perform mechanical testing, and interpret performance data.
Working knowledge of design controls, risk management, ISO 14971, ISO 13485, and 21 CFR 820.
Familiarity with relevant device specific standards such as ISO 10555, ISO 11070, ISO 5840, ISO 25539, and others.
Strong problem solving skills with clear and concise technical communication.

Nice To Haves

Experience with complex multilumen shaft constructions or devices that incorporate imaging, ablation, or therapeutic components.
Background in DFM for catheter assembly including braiding, laser processing, bonding, and thermoforming.
Experience developing devices for structural heart or aortic applications.

Responsibilities

Participate in or lead the design and development of complex steerable catheters including deflection systems, pull wire mechanisms, torque transfer structures, and integrated components.
Create design concepts, detailed models, drawings, and specifications using 3D CAD tools.
Perform design analysis including tolerance studies, mechanical evaluations, and material selection.
Build and refine prototype devices through hands on bench work and structured testing.
Lead or support design verification activities including DV planning, development of test methods and procedures, and execution of mechanical and simulated use testing.
Support the creation of manufacturing processes in collaboration with operations, tooling, and quality teams.
Prepare documentation including design history file elements, risk management documents, protocols, and reports.
Translate user needs and clinical requirements into clear and actionable design inputs.
Contribute to project planning, cross functional communication, and milestone execution.
Ensure all work complies with applicable regulatory and quality system requirements.