At Johnson & Johnsonwe believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented treated and curedwhere treatments are smarter and less invasive andsolutions are our expertise in Innovative Medicine and MedTech 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 more at

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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 were developing the next generation of smarter less invasive more personalized treatments. Ready to join a team thats 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.

Essential Job Functions

• 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

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 Associates 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

Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race color religion sex sexual orientation gender identity age national origin disability protected veteran status or other characteristics protected by federal state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.

Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants needs. If you are an individual with a disability and would like to request an accommodation please contact us via or contact AskGS to be directed to your accommodation resource.

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