Operator II - 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 II – 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.   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.    Provide suggestions for process improvements.   Identifies rejects, explains root cause, and provides solutions for process improvements.   Trains to become Subject Matter Expert (SME) at their workstations and trainer for the line.   Champions and supports the In-Process Kanban (IPK) integrity.   Adheres to Lean Manufacturing practices on the floor.   Continuously trains and masters up to 6 operations and rotates assembly stations as needed to meet production goals.   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.     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.   1-3 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 but not limited to 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 for special assignments.   Capable of filling out detailed LHRs while following Good Documentation Practices (GDP).   Ability to work in a fast-pa