Position Summary
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 (SolidWorks or similar)
- Experience supporting regulatory submissions