Catheter Engineer

About the Company

Remedy Robotics is a medical technology company developing robotic systems for endovascular intervention. Its proprietary technology combines robotics, machine learning, and advanced computer vision to help physicians perform highly precise endovascular procedures and expand access to life-saving stroke and cardiovascular care.

Responsibilities

• Lead end-to-end design and engineering of steerable catheter products from concept through commercialization
• Author design specifications, design history files (DHFs), risk analyses (FMEA/FTA), and V&V protocols
• Define design inputs and outputs in alignment with FDA 21 CFR Part 820 and ISO 13485
• Select materials and manufacturing processes with a focus on DFM/DFA
• Lead structured design transfer to contract manufacturing partners and drive process validation (IQ/OQ/PQ)
• Build and qualify the supplier base for steerable catheter components
• Coordinate V&V testing programs and author test reports for FDA submission standards
• Manage project plans, milestones, budgets, and timelines across design, regulatory, and manufacturing workstreams

Requirements

• 5+ years of medical device engineering experience focused on catheter or flexible tubular device development
• Proven track record of leading a steerable catheter through FDA regulatory clearance (510(k) or equivalent)
• Hands-on experience authoring DHFs, V&V protocols, and IQ/OQ/PQ documentation
• Experience managing contract manufacturers for catheter assembly
• Deep familiarity with FDA 21 CFR Part 820, ISO 13485, and ISO 14971

Preferred Qualifications

• Experience with balloon catheter design or multi-lumen extrusion
• Knowledge of hydrophilic and lubricious coating specification
• Experience with laser cutting processes for catheter components
• Experience with biocompatibility testing (ISO 10993)
• Proficiency in SolidWorks or equivalent CAD software