Lead Operator - Shockwave Medical

Johnson & Johnson•Santa Clara, CA

23h•Onsite

About The Position

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.

Requirements

High school diploma or equivalent experience.
Must be able to read and communicate in English.
At least five (5) years of experience in assembly of medical devices.
Requires minimal supervision for routine work and close supervision for special assignments.
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.
Capable of filling out detailed LHRs while following Good Documentation Practices (GDP).
Ability to work in a fast-paced environment while managing multiple priorities.
Operate as a team and/or independently while demonstrating flexibility to changing requirements.

Nice To Haves

Previous experience with QAD, preferable.

Responsibilities

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.
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 be required.
Initiate non-conformance reports (NCRs) as needed.
Contributes to experimental builds using documented guidelines provided by engineers to assist in the product development process.
Records results using data collection forms provided by engineers.
Contributes to the development of improved manufacturing methods by sharing ideas with engineers and management through both verbal and written communication.
Champions and leads 5S and Lean Manufacturing initiatives.
Schedules workforce and workload accordingly to meet production requirements.
Trains SMEs based on industry standards.
Supports new operators’ development and current operators’ providing continuous feedback on performance.
Enforces CER codes of conduct, policies and procedures.
Trains and is certified to all stations of 2 product lines.
Provides instructions to direct employees’ efforts.
Implements and adjusts schedules based on business needs to prevent line down situations.

Benefits

Consolidated retirement plan (pension)
Savings plan (401(k))
Long-term incentive program
Vacation –120 hours per calendar year
Sick time - 40 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
Volunteer Leave – 32 hours per calendar year
Military Spouse Time-Off – 80 hours per calendar year