Technical Publications Specialist in Fremont, CA at Stryker Corporation

Date Posted: 7/14/2019

Job Snapshot

Job Description

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 (detailed description)

  • 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
  • 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)
  • 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. 
  • Design 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. 

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. 

Qualifications/Work Experience Required

  • Associates Degree in relevant field or equivalent experience
  • At least 5 years experience in developing technical publications and/or the delivery of technical publications that are part of products -- including writing, graphic design, development of artwork/images, document control -- with part of that experience in a regulated industry.
  • Experienced in Microsoft Applications (Word, Excel, PowerPoint, Visio), Adobe Frame Maker, Photo Shop, Illustrator, Acrobat Pro Extended, InDesign.
  • Experienced in labeling design
  • Experienced in modifying Quality System documents that govern Label Design and other New Product Development processes.  
  • Experienced in leading teams to create technical documentation and quality system documentation. 
  • Preferably, experienced in Website Design and/or Support
  • Desired for Labeling & Graphics Designer, 1 - 3yrs experience in Solid Modeling / SolidWorks to support editing of existing drawings and or design of packaging components.
  • Demonstrated ability to multi-task in a high volume, quick paced environment
  • Demonstrated detail orientation
  • Demonstrated organization, communication and interpersonal skills

    Work From Home: No

    Travel Percentage: Up to 25%

    Stryker Corporation is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status. Stryker is an EO employer – M/F/Veteran/Disability.

    Stryker Corporation will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information.

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