Operator II - Shockwave Reducer

Johnson & Johnson•New Brighton, MN

11d•Onsite

About The Position

Johnson & Johnson is hiring for a Operator II – Shockwave Reducer to join our team located in New Brighton, MN 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. Position Overview The Operator II 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. Operator records functions and activities performed on Lot History Records (LHRs) and other Quality Records, as appropriate. Operator also comply with documented requirements, company policies and procedures, including quality, safety, and environmental policies.

Requirements

High school diploma or equivalent experience.
Must be able to read and communicate in English.
1-3 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 but not limited to 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.
Able to work in a teamwork environment, create effective interpersonal relationships, and display good communication skills.
Clearly communicates with co-workers and peers.
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.
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.
Provide suggestions for process improvements.
Identifies rejects, explains root cause, and provides solutions for process improvements.
Trains to become Subject Matter Expert (SME) at their workstations and trainer for the line.
Champions and supports the In-Process Kanban (IPK) integrity.
Adheres to Lean Manufacturing practices on the floor.
Continuously trains and masters up to 6 operations and rotates assembly stations as needed to meet production goals.
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.

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
For additional general information on Company benefits, please go to: - https://www.careers.jnj.com/employee-benefits
Volunteer Leave – 32 hours per calendar year
Military Spouse Time-Off – 80 hours per calendar year