Labeling Engineer

Labeling Engineer

6 Month Contract (Potential to be converted into full time)

Hybrid role in Santa Clara, CA

Position Overview

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 Functions

Support labeling activities for new products, commercial products, clinical builds from initiation to implementation

Work 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 plan

Perform labeling project updates to impacted stakeholders and maintain a communication channel throughout all the phases of the project

Coordinate with the labeling designer/technician during artwork development and work collaboratively to resolve any issues related to label scripting/coding/symbols

Develop 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

Requirements

Bachelor’s degree in engineering or engineering discipline (Biomedical, Industrial, etc).

Knowledge of PLM, ERP, and or MES is preferred but not required.

Minimum of three (3) years of relevant experience in labeling for the medical device industry.

Knowledge of compliance with applicable Quality System requirements such as QSRs, FDA, ISO 11607, MDR, MDSAP and other applicable regulations related to labeling.

Knowledge of documentation management and understanding of Good Manufacturing Practices (GMPs).

Ability to use labeling design software.

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.