Aequor ยท 1 month ago
Steerabel R&D Engineer (MEDICAL DEVICE)
Aequor is seeking a Medical Device Engineer with expertise in the design and development of complex steerable catheters. This role involves hands-on technical development, contributing throughout the full product lifecycle, and ensuring compliance with regulatory and quality system requirements.
ConsultingIT ManagementRecruiting
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
Aequor
Since 1998, Aequor has provided exceptional workforce staffing services in multiple industries.
H1B Sponsorship
Aequor has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (2)
2024 (2)
2023 (1)
2022 (3)
2021 (1)
2020 (5)
Funding
Current Stage
Growth StageRecent News
Staffing Industry Analysts
2023-12-24
2023-07-11
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