Packaging and Labeling Technician - Shockwave Medical
$40,250–$64,803 year
On-siteSanta Clara, California, United States
Job Summary
Monitor and improve manufacturing processes for packaging, labeling, and printing, identifying opportunities to enhance efficiency, quality, and product flow. Set up, operate, maintain, and inspect equipment such as sealing machines and inspection tools according to standard operating procedures. Evaluate and analyze workflows to implement continuous improvements, draft standard operating procedures, and assist in equipment validations. Troubleshoot complex labeling issues, proof labeling materials against source files, and draft specifications for product labels in compliance with regulatory requirements. Provide support data to engineers for feasibility and qualification studies while maintaining high attention to detail in document updates.
Required Qualifications
- High School diploma or GED
- 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
- 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
- Availability for occasional Saturday production support may be required based on business needs
- Ability to lift objects up to 25lbs or more
- Proficiency in Microsoft Office Word, Excel, & Outlook
- Proficiency with Adobe Professional Product and label design software (Seagull Bartender)
Desired Qualifications
- Experience with equipment preventive maintenance and or calibration
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