Packaging Engineer II

Shockwave Medical, Inc. is a pioneer in the development and commercialization of Intravascular Lithotripsy (IVL) to treat complex calcified cardiovascular disease. Shockwave Medical 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 Engineer II is responsible to support packaging and labeling processes for established and new product lines.

• 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 design, develop and test a wide variety of packaging used for the protection, display, and handling of products such as aging studies, preconditioning, transportation, and testing.
• Determine 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.
• Assist in designing outer package considering such factors as product identification, sales appeal, aesthetic quality, printing, and production techniques
• 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.

• Bachelor's degree in Manufacturing Engineering or Engineering discipline (Mechanical, Biomedical, etc.
• Minimum of three (3) years of experience in packaging, printing and label creation.
• 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.

Benefits
Shockwave Medical offers a competitive total compensation package as well as the following benefits and perks:

Core Benefits:Medical, Dental, Vision, Pre-tax and Roth 401k options with a fully vested match, Short-Term and Long-Term Disability, and Life Insurance, Employer contribution toward Health Savings Account (HSA), Competitive PTO balance

Perks: Calm App, Pet Insurance, Student Loan Refinancing, Spot Bonus awards

EEO Employer