Principal R&D Technician; Extrusion - Shockwave Medical

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Location:

Santa Clara, California, United States of America

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and Med Tech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity.

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R&D Operations

Product Development Testing

Business Enablement/Support

The Principal R&D Technician (Extrusion Technology) will work closely with R&D Engineers to support the polymer extrusion development and optimization of polymer tubing extrusion processes for medical devices. This role involves hands‑on operation of extrusion equipment, fabrication of plastic tubing prototypes, including single‑ and multi‑lumen configurations, and providing feedback for continuous design and process improvements. The Principal R&D Technician will also be responsible for testing extruded tubing, accurately documenting process parameters and results, and maintaining all related logs, forms, and records.

This role is a subject matter expert in extrusion technology, detail‑oriented, and thrives in a collaborative, fast‑paced R&D environment.

• Responsible for technical development of extrusion processes, tooling and equipment for extruded products
• Ability to work with minimal direction and use good judgement and previous experience to bring a concept to reality
• Create and maintain accurate documentation of tool drawings, design concepts and concepts, maintain documentation per quality system requirements (e.g., drawings, protocols, reports)
• Proactively recommends new ideas and/or improvements pertaining to design and process
• Analyze, evaluate, source, and coordinate the procurement of new polymer materials to support prototyping and pilot operation
• Support the development of test methods and protocols/reports for in‑vitro, in‑vivo as well as verification and validation testing
• Responsible for component and assembly documentation for new products being developed
• Lead and mentor other technicians to reach departmental and company objectives
• Partner with engineers to design and assemble functional prototypes and provide feedback on assembly process and design
• Drive equipment procurement, installation (IQ, Calibration, Maintenance)
• Assist engineers with product and process design, development, and optimization
• Initiates root cause investigation and analysis
• Perform equipment installation and qualification
• Lead product and process characterization and design verification testing
• Prepare test samples (products/materials/solutions) for routine and qualification testing
• Design and fabrication of fixtures and tooling for product builds and testing (i.e., pneumatic, electrical, hydraulic)
• Responsible for the maintenance and troubleshooting of lab instruments/equipment
• Create and maintain accurate documentation of concepts, designs, drawings, test methods and processes
• Train other technicians, assemblers and engineers on procedures and product assembly
• Develop and draft Manufacturing Process Instructions
• Other duties as assigned

• High School Diploma required with a minimum of 10 years’ experience as R&D Technician (or relevant experience) in the medical device industry or Associate’s degree with a minimum of 8 years’ experience as an R&D Technician in the medical device industry
• Minimum 2 years’ experience in a polymer plastic extruder manufacturing environment
• Knowledge of plastics, extrusion process, material selection and testing
• Ability to communicate effectively with all cross‑functional team members
• Familiar with Good Manufacturing Practices (GMP), Good Documentation Practices (GDP) and laboratory practices
• Machine shop experience is preferred
• Proficient with MS Office
• Comfortable working in…