Sr. R&D Technician

The Senior R&D Technician plays a critical hands-on role in the development of innovative catheter-based medical devices. This position supports product development from concept through commercialization by building prototypes, conducting design verification testing, and collaborating cross-functionally with Engineering, Quality, Manufacturing, and Regulatory teams. The ideal candidate has strong experience working with catheter systems, polymers, extrusion, and precision assembly in a regulated medical device environment.

Key Responsibilities

• Build and assemble catheter prototypes and subassemblies (shaft assemblies, tip forming, bonding, braiding, etc.)
• Support design and development activities including feasibility builds, design iterations, and engineering builds
• Conduct verification and validation testing (mechanical, tensile, burst, torque, trackability, kink resistance, etc.)
• Develop, document, and execute test methods and protocols
• Maintain accurate documentation in compliance with FDA QSR (21 CFR Part 820), ISO 13485, and internal procedures
• Support root cause investigations and failure analysis
• Collaborate with R&D Engineers to refine product designs and optimize manufacturability
• Support process development including extrusion, reflow, heat forming, bonding, and assembly techniques
• Operate and maintain laboratory equipment (Instron, burst testers, torque testers, microscopes, etc.)
• Assist in design transfer to manufacturing
• Train and mentor junior technicians as needed
• Maintain organized lab space and manage prototype materials inventory

Required Qualifications

• Associate degree in Engineering Technology, Biomedical Engineering Technology, or related field (Bachelor’s preferred)
• 5+ years of hands-on experience in medical device R&D, preferably with catheter-based systems
• Strong experience with catheter assembly techniques (heat shrink reflow, lamination, tipping, braiding, bonding)
• Familiarity with polymer materials used in catheters (Pebax, Nylon, PTFE, etc.)
• Experience working in a regulated medical device environment (FDA, ISO 13485)
• Proficiency with mechanical test methods and lab equipment
• Ability to read and interpret engineering drawings and specifications
• Strong documentation and technical writing skills

Preferred Qualifications

• Experience supporting design verification (DV) and validation (PV) activities
• Knowledge of Design Controls and risk management (ISO 14971)
• Experience with catheter extrusion or braided shaft construction
• Basic CAD familiarity (Solid Works or similar)
• Experience supporting regulatory submissions