R& D Engineer- Complex and Steerable Catheters (Medical Device)
- 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.
Required Qualifications
- 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.
Preferred Qualifications
- 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.
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