Principal R&D Technician (Extrusion) - Shockwave Medical

Johnson & Johnson•Santa Clara, CA

1d•$69,000 - $111,090•Onsite

About The Position

Johnson & Johnson is hiring for a Principal R&D Technician – Shockwave Medical to join our team located in Santa Clara, CA. Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments. Ready to join a team that’s pioneering the development and commercialization of Intravascular Lithotripsy (IVL) to treat complex calcified cardiovascular disease. Our Shockwave Medical portfolio aims to establish a new standard of care for medical device treatment of atherosclerotic cardiovascular disease through its differentiated and proprietary local delivery of sonic pressure waves for the treatment of calcified plaque. Position Overview 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.

Requirements

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 a clean room environment
Ability to work in a fast-paced environment while managing multiple priorities
Operate as a team and/or independently while demonstrating flexibility to changing requirements
Employee may be required to lift objects up to 25lbs

Responsibilities

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

Benefits

Subject to the terms of their respective plans, employees are eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).
This position is eligible to participate in the Company’s long-term incentive program.
Subject to the terms of their respective policies and date of hire, employees are eligible for the following time off benefits:
Vacation –120 hours per calendar year
Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado –48 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year
Holiday pay, including Floating Holidays –13 days per calendar year
Work, Personal and Family Time - up to 40 hours per calendar year
Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child
Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
Caregiver Leave – 80 hours in a 52-week rolling period10 days
Volunteer Leave – 32 hours per calendar year
Military Spouse Time-Off – 80 hours per calendar year