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 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.

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

• Subject to the terms of their respective plans, employees are eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).
• This position is eligible to participate in the Company’s long-term incentive program.
• Subject to the terms of their respective policies and date of hire, employees are eligible for the following time off 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

What This Job Offers

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