Loretta

About Loretta

An accomplished and competent product label specialist with expertise in the designing of all marketing materials including PowerPoint presentations, custom product packaging designs, large billboards, and labels for Hispanic food markets and services. Effectively create and modify product labels and packaging to ensure compliance with all regulatory design formats. Hands-on experience with designing a new responsive website, managing digital contents, keynote presentations, brochures, business proposals, labeling, packaging, app wireframes, clinical trial documentation, reference guides, Medical technical writing for CuraSeal Medical Devices using Creative Suite.

Experience

1. Labeling Engineer

   Shockwave Medical

   Apr 2025 — Present · Santa Clara, CA, US

   The Labeling Engineer completes all work related to the creation of new labeling, updates, or changes to labeling content (labels, IFU, Implant Cards, etc.) following the document change control process established at Shockwave and ensures is carried out in compliance with Shockwave’s labeling procedures. The Labeling Engineer works collaboratively with Regulatory to remain in compliance with the global labeling standards and regulations for the medical device industry and coordinates implementation of labeling changes into production with all impacted stakeholders. Essential Job FunctionsSupport labeling activities for new products, commercial products, clinical builds from initiation to implementationWork collaboratively with Regulatory Affairs to create new labels and determine labeling content based on procedures, standards, and regulations.Manage the labeling change process from initiation to implementation to meet established timelines and negotiate exceptions to planPerform labeling project updates to impacted stakeholders and maintain a communication channel throughout all the phases of the projectCoordinate with the labeling designer/technician during artwork development and work collaboratively to resolve any issues related to label scripting/coding/symbolsDevelop and maintain documentation for labeling content and label creation.Create and manage change requests within the document control system.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.Ability to learn and support systems integration projects like PLM, ERP, MES

Education

• UCSC Silicon Valley Extension

  Web Developement and App Certification, Web Developement and Applications

• UCSC Silicon Valley Extension

  Certification, User Experiences and Web Design

  2018 — 2019

• Advertising Designer

  Associate's degree, Advertising Design

Skills

• Dreamweaver
• Layout
• Illustrator
• Adobe Creative Suite
• Graphics
• Illustration
• Indesign
• Creative Direction
• Adobe Acrobat
• Brochures
• Corporate Identity
• Multimedia
• Flash
• Mac
• Css
• Photoshop
• Graphic Design
• Html
• Typography
• Web Design
• Advertising
• Flyers
• Quarkxpress
• Packaging
• Posters
• Photography
• After Effects
• Web Development
• Marketing
• Business Cards
• SEO
• Presentation Design
• Adobe Muse
• Art Direction
• Adobe Photoshop
• Poster Design
• Page Layout
• Adobe Illustrator