Remedy Robotics
Medical Technology
CatheterEngineer
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“Catheter Engineer at Remedy Robotics. Skills: Catheter Design, Medical Device Engineering, Regulatory Approval, Contract Manufacturing. Lead end-to-end design and engineering of steerable catheter products. Author and own design specifications”
What You'll Achieve.
commercialization; manufacturing requirements are clearly defined, documented, and controlled; designs are manufacturable at target cost and quality levels; FDA submission standards; post-market surveillance; prototype builds through first commercial shipment; distribution readiness
Industry & Context.
Risk Analyses; FMEA; FTA; Regulatory Risks; Supply Risk Management
What They're Looking For.
Must Have
5+ years of medical device engineering experience, focus on catheter or flexible tubular device development, Demonstrated track record of taking a steerable catheter through FDA regulatory clearance or approval (510(k) or equivalent) as the lead engineer, Hands-on experience authoring DHFs, V&V protocols, IQ/OQ/PQ documentation, and regulatory submission technical sections, Proven experience managing contract manufacturers for catheter assembly, Deep familiarity with FDA 21 CFR Part 820, ISO 13485, ISO 14971
Nice to Have
Experience with balloon catheter design, multi-lumen extrusion, Hydrophilic and lubricious coating specification and qualification, Laser cutting processes for catheter components, Biocompatibility testing (ISO 10993), CAD proficiency (SolidWorks or equivalent)
What You'll Do.
Lead end-to-end design and engineering of steerable catheter products
Author and own design specifications
Define and document design inputs and outputs
manufacturing processes
and design architectures
Own BOM structure and routing
Lead structured design transfer to contract manufacturing partners
Drive process validation programs
Conduct DFM/DFA reviews
Build and qualify the supplier base
Manage ongoing supplier quality
Coordinate V&V testing programs
Maintain and update technical files and DHFs
Proactively identify and mitigate regulatory risks
Serve as the primary technical interface with contract manufacturing partners
Drive component sourcing
and supply risk management
Manage supplier quality requirements
and resource coordination
Manage budgets and timelines for development programs
Coordinate product launch logistics
Provide regular project status updates
How You'll Work.
Team & Collaboration
cross-functional project leadership; resource coordination across design, regulatory, manufacturing, and quality workstreams
Process & Methodology
Project Plans, Milestones, Resource Coordination, Budget Management, Timelines, Project Status Updates
Full Job Description
Remedy Robotics https://www.remedyrobotics.com/ 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. Initially focused on neurovascular intervention, Remedy is addressing the limited availability of specialized treatment for time-critical cardiovascular emergencies, with the long-term goal of enabling expert intervention regardless of patient location. Headquartered in San Francisco, Remedy is backed by DCVC, Blackbird, and Tony Fadell's Build Collective, among others. We are seeking an experienced Catheter Engineer to own the design, development, and regulatory approval of a broad range of catheter-based medical devices. This is a high-impact, hands-on role for a technically deep engineer who thrives at the intersection of product development, regulatory strategy, and cross-functional project leadership. What You'll Do: Design & Development - Lead end-to-end design and engineering of steerable catheter products, from concept through commercialization. - Author and own design specifications, design history files (DHFs), risk analyses (FMEA/FTA), and verification & validation protocols. - Define and document design inputs and outputs in alignment with FDA 21 CFR Part 820 and ISO 13485 quality systems. - Select materials, manufacturing processes, and design architectures appropriate for catheter performance, biocompatibility, and manufacturability - with a strong eye toward DFM/DFA. - Own BOM structure and routing management; maintain accurate manufacturing records in compliance with ISO 13485. Design Transfer & Manufacturing Ramp - Lead structured design transfer to contract manufacturing partners, ensuring manufacturing requirements are clearly defined, documented, and controlled. - Drive process validation pr
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