Operator III - Shockwave Medical

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 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 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. 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 for special assignments. Capable of filling out detailed LHRs while following Good Documentation Practices (GDP). Ability to work in a fast‑paced environment while adhering to SWMI safety standards. Ability to work overtime to accommodate business needs. Reliable attendance. There may be continuous sitting for prolonged periods and may be required to lift objects up to 15 pounds. Required Skills — Preferred Skills Administrative Support Agile Manufacturing Assembly Operations Communication Execution Focus Factory Acceptance Test (FAT) Good Manufacturing Practices (GMP) Innovation Learning Agility Manufacturing Processes Manufacturing Science and Technology (MSAT) Mechanical Equipments Plant Operations Process Oriented Prototyping Repair Management Structural Fabrication Technologically Savvy Salary Information The anticipated base pay range for this position is: $47,150.00 - $76,705.00 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 Equal Opportunity Employer Statement 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. #J-18808-Ljbffr Shockwave Medical