Remedy Robotics
Catheter Engineer
San Francisco
Sponsorship not specifiedDetected 56 days ago
Machine LearningComputer VisionProject ManagementSupply ChainLogisticsSolidWorksRoboticsFDA RegulatoryMedical DevicesLeadership
About the role
- 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.
Responsibilities
- 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 programs (IQ/OQ/PQ) from protocol authorship through execution and report approval.
Requirements
- Proven experience managing contract manufacturers for catheter assembly.
Nice to have
- Experience with balloon catheter design or 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)
Benefits
- Remedy Robotics https://www.remedyrobotics.com/ is a medical technology company developing robotic systems for endovascular intervention.
- We are seeking an experienced Catheter Engineer to own the design, development, and regulatory approval of a broad range of catheter-based medical devices.
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This listing is sourced directly from Remedy Robotics's careers page and normalized into a canonical job model.