Remedy Robotics
Medical Technology
CatheterEngineer
“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
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