Lead Operator - 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 Lead Operator - Shockwave Medical 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 Production Lead 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.  Supports Production Supervisors to coordinate schedules and workload to meet production requirements. Records functions and activities performed on Lot History Records (LHRs) and other Quality Records. Leads the efforts of their assembly team to comply with the company’s policies and procedures, including quality, safety, environmental, and business practices. The Production Lead is considered the Subject Matter Expert (SME) on all stations of the assigned product line.

Essential Job Functions

• Reviews LHR to ensure correct documentation is at workstation(s); obtains new documentation (i.e., latest MI revision) from supervisor or lead, if necessary.

• Setup equipment obtains tools and materials required by LHR.

• Cleans workstations/equipment and performs line clearance per documented procedures.

• Signs/dates documentation to verify completion of setup procedures.

• Builds subassemblies and/or final assemblies per MPIs.

• Performs in‑process inspections (i.e., qualitative [visual or tactile] and quantitative [dimensional]) of components/materials, subassemblies, and final assemblies to ensure that specifications are met and/or for data collection and analysis (e.g., statistical process control [SPC]).

• 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 (e.g., part number, description, expiration date), and assembles final product packaging.  Records and dispositions labeling materials used, destroyed, and leftover from packaging operations.

• Ensures that only products labeled correctly are released to finished goods according to documentation. 

• Records details of work and completes required portions of LHR to ensure traceability of each finished product lot. Assists supervisor with inventory control issues (e.g., scrap transactions, back flushing of finished products and subassemblies). Completes LHRs for review.

• Records process and product measurement data for quality control purposes, as required. 

• 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