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Job Description:

Johnson & Johnson is hiring for a Sr. Packaging Engineer to join our team located in Shockwave Medical Costa Rica.

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 Senior Packaging Engineer is responsible to support packaging and labeling processes for established product lines. Develop packaging and labeling for new products.

Essential Job Functions

Essential Job Functions

• Work collaboratively with R& D, QA and Production departments to develop, test, document, validate and implement labeling and packaging processes.
• Select, procure, install, and validate packaging and labeling equipment.
• Assist in conducting Process FMEAs
• Identify and implement packaging/labeling process improvement projects.
• Support development and testing of a wide variety of packaging used for the protection, display, and handling of products such as aging studies, preconditioning, transportation, and testing.
• Define packaging specifications according to the nature of the product, cost limitations, legal requirements, and the type of protection required, considering need for resistance to such external variables as corrosive chemicals, temperature variations, moisture, UV light, heat, transportation effects.
• Develop and maintain documentation for design control, product configurations, manufacturing procedures, lot history records, (e.g., bills-of-materials, MPI’s, LHR’s), and other Quality System requirements
• Create and manage change requests within the document control system.
• Lead and/or actively participate in product/process engineering problem solving using DMAIC methodology.
• Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.
• Perform other related duties and responsibilities, on occasion, as assigned.

Requirements

• Bachelor's degree in Manufacturing Engineering or Engineering discipline (Mechanical, Biomedical, etc). Or equivalent combination of education and work experience.
• Minimum of five (5) years of experience in packaging, printing and label creation.
• Overall years of experience 7+ (Preferred)
• Visa required
• Advance English skills
• Knowledge of compliance with applicable Quality System requirements such as QSRs, FDA, ISO 11607, MDR, MDSAP and other applicable regulations.
• Knowledge of documentation management and understanding of Good Manufacturing Practices (GMPs).
• Experience with Packaging Validation of Medical Devices (IQ-OQ-PQ).
• Experience with Lean and Lean Sigma concepts.
• Experience in Statistics (Cpk, Hypothesis Testing, DOE, Gage R& R) a plus.
• Ability to use special software such as: Solidworks, Minitab or closely related.
• 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.
• Employee may be required to occasionally lift objects up to 25lbs.

An pre-identified candidate for consideration has been identified. However, all applications will be considered.