Aptyx · 1 week ago
R& D Engineer- Complex and Steerable Catheters (Medical Device)
Charlotte, NC
Full-time
Onsite
Mid, Senior Level
3+ years expAptyx is seeking a Medical Device Engineer with strong experience in the design and development of complex steerable catheters. This role involves hands-on technical development and contributions throughout the full product lifecycle, including design, prototyping, and regulatory compliance.
ManufacturingPlastics and Rubber Manufacturing
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
Qualification
Required
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
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
Company
Aptyx
Aptyx has developed an excellent reputation as an industry leader in plastics processing with process offerings.
1001-5000 employees
Funding
Current Stage
Late StageTotal Funding
$17.5MKey Investors
PNC Mezzanine CapitalCVF Capital Partners
2022-08-08Acquired
2015-12-31Debt Financing· $11.5M
2012-12-12Debt Financing· $6M
Leadership Team
Gregg Tobin
President & Chief Executive Officer
Michelle Ferrari
Human Resource Business Partner
Recent News
Medical Product Outsourcing
2025-12-08
2025-12-05
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