Packaging and Labeling Technician - Shockwave Medical

Shockwave Medical; Santa Clara (CA); On-site; USD 40,000 - 65,000; Full time

Benefits offered by this job

Medical insurance

Retirement plan (401(k))

Paid time off

Job summary

Johnson & Johnson in Santa Clara, CA, is hiring a Packaging and Labeling Technician to support Shockwave Medical products. You will oversee labeling, packaging equipment, and document control in a fast-paced medical device environment.

The role focuses on equipment setup, process improvement, and collaboration with Engineers to ensure compliant labeling and packaging for cutting-edge intravascular therapy products.

Qualifications

• High School diploma or GED or equivalent experience.
• Minimum of three years in a medical device environment.
• Knowledge of Quality System requirements (QSRs, ISO, MDD).
• Knowledge of label and barcode standards (GS1, ISO 15416, 1D/2D).
• Understanding of 5S and Lean in manufacturing.

Responsibilities

• Labeling and packaging equipment, process, and materials improvement.
• Evaluate manufacturing processes to improve efficiency and quality.
• Improve product flow, 5S, and mistake-proofing in manufacturing.
• Set up, operate, maintain, inspect & clean packaging equipment.
• Assist in equipment validations (IQ, OQ, PQ) and change control.

Skills

Quality Systems

Labeling standards

5S/Lean

Equipment maintenance

Communication skills

Teamwork

Microsoft Office

BarTender

Education

High School diploma or GED

Tools

Bartender

GS1 standards

Barcode systems

Job description

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, andsolutions 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

Production Equipment Repair & Maintenance

Job Category

Business Enablement/Support

All Job Posting Locations

Santa Clara, California, United States of America

Job Description

Johnson & Johnson is hiring for a Packaging and Labeling Technician - Shockwave Medica 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 Packaging/Labeling Technician performs complex or specialized technical assignments usually in the nature of projects, which requires the ability to work independently. Uses considerable judgment, a high degree of initiative, creative approaches in troubleshooting, and adapts to rapidly shifting priorities and a fast-paced environment. The Packaging/Labeling Technician monitors and improves manufacturing processes related to Packaging, Labeling, & printing and makes recommendations for continuous improvement of work processes for Manufacturing Engineering.

Essential Job Functions

• Accountable for labeling and packaging equipment, process, and materials improvement
• Evaluates and analyzes manufacturing processes to find ways to improve efficiency and quality.
• Identifies opportunities to improve product flow, 5S, and mistake proofing in the manufacturing/packaging process, and implements process improvements alongside engineers
• Set up, operate, maintain, inspect & clean all packaging equipment (e.g., printing, inspection system/tools, sealing machine, and package equipment) according to standard operating procedure and manuals.
• Assist in execution of equipment validations (IO, OQ. &PQ)
• Provides support data to Engineers for feasibility, qualification and/or validation studies.
• Assist in drafting Standard Operating Procedure for labeling and packaging equipment
• Assist in design or improving packaging components for existing or up-coming products
• Draft specification for packaging designs and components
• High attention to detail in updating documents and reviewing documents/workflows
• Assist in designing and formatting of product labels for new and existing medical device products in compliance with medical, legal, internal, and external regulatory requirement
• Draft label specification for product labels
• Proof labeling material documents against source files to ensure meet established specifications.
• Assist in the routing of product labels changes for review and approval in change control system,
• Investigate and troubleshoot complex labeling issues
• Proficiency in Microsoft Office Word, Excel, & Outlook
• Proficiency with Adobe Professional Product and label design software (Seagull Bartender)
• Availability for occasional Saturday production support may be required based on business needs.
• 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.

Requirements

• High School diploma or GED or equivalent experience
• Minimum of three (3) years’ of experience in a medical device environment or equivalent experience in a similar work environment.
• Knowledge of and experience with: Quality System requirements (e.g., QSRs, ISO, MDD).
• Knowledge of label and barcode standards and specification (e.g. GTN, GS1, ISO 15416, 1D & 2D barcode, etc.)
• Understanding and experience with 5S, Lean and waste reduction in manufacturing.
• Experience with equipment preventive maintenance and or calibration a plus.
• Written and verbal communication skills to communicate effectively at all levels.
• 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 (more than 2 consecutive hours in an 8-hour day)
• Employee may be required to lift objects up to 25lbs or more. Employees will be required to work in an air-conditioned office space and possibly perform some tasks in our non-controlled temperature warehouse space.

NOTE: This job description is not intended to be all-inclusive. Employee may perform other related duties as assigned or negotiated to meet the ongoing needs of the organization.

Additional Information

• The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation’s performance over a calendar/performance year. Bonuses are awarded at the Company’s discretion on an individual basis.
• Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance.
• Employees may be eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).

Employees are eligible for the following time off benefits:

• Vacation - up to 120 hours per calendar year
• Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington - up to 56 hours per calendar year
• Holiday pay, including Floating Holidays - up to 13 days per calendar year
• Work, Personal and Family Time - up to 40 hours per calendar year

Additional information can be found through the link below. https://www.careers.jnj.com/employee-benefits

Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.

Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, please contact us via https://www.jnj.com/contact-us/careers or contact AskGS to be directed to your accommodation resource.

Required Skills

Preferred Skills:

Agile Manufacturing, Analytical Reasoning, Detail-Oriented, Equipment Maintenance, Good Manufacturing Practices (GMP), Issue Escalation, Manufacturing Equipment, Plant Operations, Predictive Maintenance, Problem Management, Process Oriented, Product Installation, Professional Ethics, Repair Management, Time Management, Troubleshooting

The anticipated base pay range for this position is :

$40,250.00 - $64,802.50