Operator III - Shockwave Medical

Johnson & Johnson Innovative Medicine • Santa Clara, CA

1d • $47,150 - $76,705 • Onsite

About The Position

Johnson & Johnson is hiring for an Operator III – Shockwave Medical to join their team in Santa Clara, CA. This role is part of a team pioneering the development and commercialization of Intravascular Lithotripsy (IVL) to treat complex calcified cardiovascular disease. The 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.

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.
• 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.

Nice To Haves

• Medical device manufacturing experience is preferred.

Responsibilities

• 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.

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 period
• 10 days Volunteer Leave – 32 hours per calendar year
• Military Spouse Time-Off – 80 hours per calendar year

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: High school or GED