Lead Operator Shockwave Medical

At Johnson & Johnsonwe believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented treated and curedwhere treatments are smarter and less invasive andsolutions are 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 more at

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.

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Johnson & Johnson is hiring for aLead Operator - Shockwave Medicalto join our team located inSanta Clara CA.

Fueled by innovation at the intersection of biology and technology were developing the next generation of smarter less invasive more personalized treatments. Ready to join a team thats 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 companys 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 inprocess inspections ( 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 inprocess 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 ( 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 ( 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 (-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.

• Other duties as assigned. These job requirements are not intended to be construed as an exhaustive list of all responsibilities duties and skills required of personnel.

• Provides instructions to direct employees efforts. Implements and adjusts schedules based on business needs to prevent line down situations.

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.

• Previous experience with QAD preferable.

• 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.

• There may be continuous sitting for prolonged periods and may be required to lift objects up to 15 pounds.

Additional Information

Subject to the terms of their respective plans employees are eligible to participate in the Companys consolidated retirement plan (pension) and savings plan (401(k)).

This position is eligible to participate in the Companys 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

• 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

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