Operator III - Shockwave Medical

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 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 humanity. Learn more at jnj.com As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world.  We provide an inclusive work environment where each person is considered as an individual.  At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit. Job Function: Supply Chain Manufacturing Job Sub Function: Manufacturing Assembly Job Category: Business Enablement/Support All Job Posting Locations: Santa Clara, California, United States of America Job Description: Johnson & Johnson is hiring for a Operator III – Shockwave Medica l to join our team located in Santa Clara, CA. 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 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 humanity. Learn more at https://www.jnj.com/. 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 Operator is responsible for assembly, testing, and inspection of product according to documented Manufacturing Process Instructions (MPIs), including cleaning and setup of workstation with proper equipment and materials.  Operator records functions and activities performed on Lot History Records (LHRs) and other Quality Records, as appropriate. Operator also comply with documented requirements, company policies and procedures, including quality, safety, and environmental policies.     Essential Job Functions   Cleans workstations/equipment and performs line clearance per documented procedures.   Builds subassemblies and/or final assemblies per MPIs.   Performs in‑process inspections of components/materials, subassemblies, and final assemblies to ensure that specifications are met for data collection and analysis.   Monitors equipment parameters and results of in‑process inspection(s); as necessary, adjusts according to documented procedures to ensure product meets appropriate quality specifications.   Prepares labeling, audits labeled product for product information per LHRs and assembles final product packaging.  Records and dispositions labeling materials used, destroyed, and leftover from packaging operations, as required.   Ensures that only products labeled correctly are released to finished goods according to documentation.     Prepares packaging for shipment, adheres to inventory control labeling, and verifies that quantity of boxed product matches quantity recorded on LHR, as required.   Records details of work and completes required portions of LHR to ensure traceability of each finished product lot.  Assists supervisor and/or lead with inventory control issues (e.g., scrap transactions, back flushing of finished products and subassemblies).     Documents scrap resulting from out-of-specification equipment, materials, processes (i.e., non-conforming materials) according to documented procedures and notifies supervisor that disposition and/or corrective action may be required.     Adheres to SWMI safety standards.   Trains and is certified to at least, one full assembly line.   Sets up work for the shift, prepares kits and corresponds with other departments.   Directs workforce based on business needs in absence of Lead/Supervisor.   Supports Engineering in absence of Lead/Supervisor (Provide labor, scheduling and acting as SME).   Implements 5S practices and Lean Manufacturing principles.   May contribute to pilot development builds using documented guidelines provided by engineers and providing feedback for improved manufacturing methods to assist in the product development process.     Promotes a positive teamwork environment, create effective interpersonal relationships, and display good communication skills. Communicates clearly with co-workers and peers.   An internal pre-identified candidate for consideration has been identified. However, all applications will be considered. Requirements   High school diploma or equivalent experience.   Must be able to read and communicate in English.   At least three (3) years of experience in a manufacturing environment with small parts. Medical device manufacturing experience is preferred.   Must be able to work in and abide by Controlled Environment Room (CER) procedures.   Ability to assemble, and test medical devices, including soldering, gluing, and assembly under the microscope while following Manufacturing Process Instructions (MPI), Standard Operating Procedures (SOP), Work Instructions (WI), etc.    Requires moderate supervision for routine work and close supervision