Catheter Engineer

Remedy Robotics
San Francisco, CA
Category Engineering
Job Description
Remedy Robotics is seeking a 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.

Requirements

  • 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.
  • Own BOM structure and routing management; maintain accurate manufacturing records in compliance with ISO 13485.
  • Lead structured design transfer to contract manufacturing partners, ensuring manufacturing requirements are clearly defined, documented, and controlled.
  • Drive process validation programs (IQ/OQ/PQ) from protocol authorship through execution and report approval.
  • Conduct DFM/DFA reviews throughout development to ensure designs are manufacturable at target cost and quality levels.
  • Build and qualify the supplier base for steerable catheter components; manage ongoing supplier quality including incoming inspection criteria and corrective actions.
  • Coordinate V&V testing programs - write protocols, oversee execution, and author test reports that meet FDA submission standards.
  • Maintain and update technical files and DHFs to support audits, NCRs, and post-market surveillance.
  • Proactively identify and mitigate regulatory risks throughout the product development lifecycle.
  • Serve as the primary technical interface with contract manufacturing partners.
  • Drive component sourcing, vendor qualification, and supply risk management for catheter subassemblies and raw materials.
  • Manage supplier quality requirements including incoming inspection and corrective action processes.
  • Own project plans, milestones, and resource coordination across design, regulatory, manufacturing, and quality workstreams.
  • Manage budgets and timelines for development programs from prototype builds through first commercial shipment.
  • Coordinate product launch logistics including labeling, packaging validation, sterility testing, and distribution readiness.
]]>