Technical Writer – Label Specialist- Fremont, CA

Come work at a first class company voted one of the top 20 employers in the country in 2015, as well as a Top Work Place in the Bay Area by the Bay Area News Group!

Candidate will be viewed as a resource who contributes to new product development and design change activities in the areas of label design, technical writing, development of artwork/images and development/ improvement of processes for improved efficiency and compliance. The resource will work as a team member as well as lead teams on special activities having business impact.

Requirements Incude:

  • Associates (+5 yrs experience) OR Bachelors Degree (+3 yrs experience)
  • Experience in Adobe Frame Maker, PhotoShop, Illustrator, InDesign, etc.
  • Experience working in a regulated industry (i.e. medical devices)
  • Experience in Labeling Design
  • Experience in modifying Quality System documents that govern Label Design

DESCRIPTION OF DUTIES

A resource who contributes to new product development and design change activities in the areas of label design, technical writing, development of artwork/images and development/ improvement of processes for improved efficiency and compliance. The resource will work as a team member as well as lead teams on special activities having business impact.

Essential Duties & Responsibilities:

• Co-authors or contributes to the creation and revision of written engineering deliverables, project management materials, and quality system materials.

• Keeps up to date on labeling-related standards/regulations and NV Quality System governing procedures/instructions; ensures compliance during labeling design.

• Completes Compliance Checklists, when changes in regulations, divisional governance, and/or labeling content emerge.

• Aids in the creation/refinement of departmental and quality system SOPs, Work Instructions, and Forms/Templates that have considerable graphics content. Creates communication and training materials that can be used by self or other staff to convey new or changed processes.

• For all assigned projects, manage, organize, and communicate the status of deliverables. For all projects for which he/she is functioning as a leader, communicate overall project information and project activities.

• Designs package and on-product labels in graphic design software as required (Adobe Illustrator, Photoshop, etc.)

• Assists in package artwork design prototyping with Marketing to develop NV styles.

• Creates redlines of product labeling as part of change order packets. Reviews and approves change orders related to product labeling

• Participates in resolving CAPAs and NCs related to product labeling, including initiating NCs.

• Mentors and directs work of Associates and Contractors.

• Builds Quality into all aspects of his/her work by maintaining compliance to all quality requirements and leading improvements that make it easier for the organization to maintain compliance in complex areas.

Label and Graphic Designer:

• Owns responsibility for label design (processes, procedures, systems)—both on-package and on-product

• Performs Label Design for Static and Dynamic design in the Stryker Neurovascular GLS system (Global Labeling System, PrisymID).

• Leads other Label Designers and trains R&D staff in how to use SNV GLS.

• Can mentor or supervise Production Artist(s) and Associate Technical Publication Specialists in label design and verification.

• Is power user of PrisymID GLS . Serves as a resource for GQO and other sites. Will serve as the GLS Data Administrator and will enter/edit/verify data into database tables.

• Designs labels in other label design systems used in MFG sites and CDCs (e.g., BarTender, LabelView).

• Performs Labeling Verification during Design Controls throughout the development process to Production Status. Partners with GQO for Label Verification in Production.

• With Divisional Marketing Branding team, develops the look and feel of product labeling (colors, formats, layout, etc.)

• Develops graphics to be incorporated into web-based distribution of end-user information.

• Draws artwork for printing on labels or cartons, on-device etchings, laser engravings, or pad printing within parameters of a pre-supplied engineering drawing (drawn by a separate drafting group in Pro-E or SolidWorks or by self)

• Creates engineering drawings in CAD system for packaging and labeling components; can create engineering drawings for devices and tooling/fixturing.

Labeling Technical Writer:

• Drives the creation/refinement of departmental and quality system SOPs, Work Instructions, and Forms/Templates that have considerable graphics content. Creates communication and training materials that can be used by self or others to convey new or changed processes.

• Prototypes designs (media, layout, graphics) for presenting information to end users: Global and Regional DFUs, Patient Cards, Quick Reference Guides, Pointer Pages

• Manages the development of end-user (physician and patient) information for hard-copy and/or web-based distribution: Global and Regional DFUs, Patient Cards, Quick Reference Guides, Pointer Pages

• According to divisional guidance, procures certified translation for each labeling type

• Coordinates activities with external vendors for translations and graphics as needed.

• Develops and maintains divisional and corporate style guides

• For support of web-based distribution of end-user information, develops and maintains under rev-control: FAQs and Tool-Tips, website language, selectable website configurations from the BackEnd, product-specific artwork consistent with branding, watermarking, connectivity with training materials developed by MKTG

• Mines and consolidates data from business systems, compilations of information, and Quality records. Organizes and places raw data into usable tables or effective graphics.

• Plans documents and creates the draft or framework of a document for technical staff. Reviews written materials for technical staff to make suggestions or corrections to make a document more clear and concise.

• Participates in or leads department projects. Projects for participation include PDP, TDP, and Sustaining projects. Projects for leadership include departmental projects and Business Initiatives. Additional project participation may include activities operating under a Quality Plan or a CAPA.