Lead R&D Technical Writing Analyst

Published
April 16, 2021
Location
Fremont, CA
Job Type

Description

Our medical technologies firm in Fremont, CA is looking for a Lead R&D Technical Writing Analyst

Job Summary:
The Senior Technical Publications Specialist, as a part of Sustaining R&D, is responsible for creating end-user regulatory complaint product labeling.
The specialist contributes to new product development and design change (sustaining) activities in the areas of label design/release, technical writing, development of artwork/images and development or improvement of processes for improved efficiency and compliance. This role will engage with and mobilize cross functional teams to resolve obstacles effectively, be responsible for meeting key labeling objectives, and lead/collaborate on continuous improvement initiatives or special activities having business impact.

Essential Duties and Responsibilities:

  • Researches and builds knowledge about products, service, technology, test method and documents in the clearest, most logical way for greatest reader comprehension
  • Drives continuous improvement (NCs and CAPAs) and assessment of current procedures, generation of quality plans and identification of best practices
  • Prepare for internal and external audits by gathering records, supporting backroom, and providing explanation for design areas developed by self with auditor in the Front Room
  • Lead recertification and other compliance projects by managing key activities with stakeholders to execute required changes and sometimes determine alternate design directions
  • Fully support the Quality Policy by building quality into all aspects by maintaining compliance to all quality requirements and supporting improvements that make it easier for the organization to maintain compliance in complex areas
  • Demonstrated extensive application of knowledge through delivery of high-quality deliverables (SOPs, technical literature and Work Instructions, engineering work product) to ensure continuity of content style that meets applicable standards and is appropriate for its intended audience
  • Strong attention to detail, reviews and audits other technical publications deliverables and consistently delivers quality documentation with no escapes
  • Leads structured problem-solving initiatives to resolve complex technical issues and document within appropriate quality system documentation
  • As regulations change and quality systems are merged/aligned, execute the creation/refinement of department and quality system SOPs, Work Instructions, forms, and templates that have considerable graphical content with minimal supervision
  • Provides input to creation of training and communication materials that can be used by self or other staff to convey new or updated processes
  • Experienced in modifying existing and creating new Quality System documentation (work instructions, standing operating procedures, forms, checklists, and templates)

Label Designer Role:

  • Support set up of new labeling templates for design changes and new product introductions and new product families using the Stryker Neurovascular labeling system
  • Power user of SNV PrisymID GLS, trains new technical publications staff
  • In consultation with the Divisional Marketing Communications Team, applies detailed knowledge of vaguely defined customer requirements, designs and develops the look and feel of product labeling (colors, formats, layout, etc.)
  • Can provide input into usability studies
  • Experienced in the labeling verification procedure/ process and partners with Operations (as needed) to implement labeling in production

Technical Writing Role:

  • Support research, develop, document and execution of technical specifications and generates test scripts for complete electronic IFU system issues
  • Monitors input of software defects and notifies for appropriate response
  • Participates in the Corporate Hub and Spoke for eIFU and other e-labeling.
  • Support IFU development and release in PLM for new product development and design changes in conjunction with product labeling to ensure congruency with strong attention to detail
  • Manages tasks related to IFU/ Literature printing suppliers

Qualifications:

  • 4-6 years of relevant experience
  • Bachelor's Degree in Graphics or Language or equivalent experience (Advanced degree may be considered towards years of experience)
  • Be required to have a high level of service and responsibility in managing a high and varied workload from internal customers and be comfortable working to tight timelines
  • Provide weekly summary of activities, create project plans, prioritize, and effectively communicate updates to customers
  • Follow Good Document practices (GDP) for all documentation created/reviewed and staying current on all required training for incumbent position
  • Qualifications/Work Experience Required:
  • Demonstrated extensive application using database driven labeling system such as Prisym ID, Label View, Loftware, Bartender Nice Label, and Easy Label.
  • Working knowledge of:
    • Adobe Suite (InDesign, Frame Maker, Photo Shop, and Illustrator)
    • Computer Aided Drafting (CAD) - Solidworks, AutoCAD
    • Experience in website design and testing
    • Microsoft applications (Word, Excel, PowerPoint, and Visio)

Benefits:
We put our Ambassadors first. When it comes down to it, we know we can't fulfill our Promise to our business customers without your com­mitment. You represent our organization while on assignment. In return, we do our best to show our commitment to you. Our Ambassador Benefits package includes: Medical, dental and vision coverage. It also includes 401k, sick time, holiday and much more. We are an equal opportunity employer.

We are an equal opportunity employer and make hiring decisions based on merit. Recruitment, hiring, training, and job assignments are made without regard to race, color, national origin, age, ancestry, religion, sex, sexual orientation, gender identity, gender expression, marital status, disability, or any other protected classification. We consider all qualified applicants, including those with criminal histories, in a manner consistent with state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance.

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