• Lead Analyst, R&D Technical Writing

    Job Location(s) US-CA-Fremont
    Posted Date 2 months ago(11/15/2019 11:56 AM)
    Job ID
    2019-31959
    Category
    Other
    Position Type
    Contract (Full-Time)
    # of Openings
    1
  • Responsibilities

    • Understands customer needs as it pertains to products, service, technology, test method, and usability and documents to provide a clear, most logical way for reader comprehension
    • Owns root cause investigations (RCAs) related to continuous improvements (NCs/CAPAs), quality plan development and execution, and assessment of current procedures and identification of best practices
    • Prepares for internal and external audits by gathering records, generating records, supporting backroom and defending design choices as Subject Matter Expert (SME) on behalf of the design team in Front Room
    • Owns root cause investigations (RCAs) related to continuous improvements (NCs/CAPAs), quality plan development and execution, and assessment of current procedures and identification of best practices
    • Prepares for internal and external audits by gathering records, generating records, supporting backroom and defending design choices as Subject Matter Expert (SME) on behalf of the design team in Front Room
    • Works with appreciable latitude for independent action or decision to lead recertification and other compliance projects in addition to influencing design directions and decisions
    • Fully support the Quality Policy by building quality into all aspects by maintaining compliance to all quality requirements and leading improvements that make it easier for the organization to maintain compliance in complex areas
    • Subject Matter Expert (SME) in one or more areas with demonstrated application of knowledge through delivery of 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.

    For Label Designer Role:

    • Lead set up of new labeling templates for design changes and new product introductions and new product families using the company's Neurovascular labeling system
    • Power user of SNV PrisymID GLS, trains new technical publications staff and serves as resource for company's Neurovascular Operations
    • Gather information from cross functional stakeholders to design and develop the look and feel of product labeling (colors, formats, layout, etc.) and documents within rocedure appropriately.
    • Can perform usability studies.
    • May direct other technical publications staff in refining existing and developing more efficient label verification and implementation process.

    For Technical Writing Role:

    • Leads research, development, documentation and execution of technical specifications and generates test scripts for complex electronic IFU system issues o Monitors input of software defects and triggers appropriate response.
    • Serves as a SME on Corporate Hub and Spoke for eIFU and other e-labeling.
    • Leads IFU development and release in PLM for new product development and design changes in consultation with label designer on product labeling to ensure congruency
    • Apply basic knowledge of clearly defined customer issues and associated tasks to manage IFU/Literature printing suppliers*
    • Provides input into designs that are compliant for targeted regions and have a high degree of usability by HCPs and patients.
    • Prepares traceability documentation.

    Qualifications

    • Over 6 years’ experience in developing or delivery of technical publications that are part of products including writing, graphic design, development of artwork/images, document control, related to engineering, with part of experience in a medical device/regulated industry:
    • 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
    • Subject Matter Expert (SME) in Microsoft Applications (Word, Excel, PowerPoint, and Visio), Adobe Suite (InDesign, Frame Maker, Photo Shop, and Illustrator)
    • Demonstrated experience in at least one of the following:
    • For Label Designer Role: Database driven labeling system such as Prisym ID, Label View, Loftware, Bartender Nice Label, and Easy Label
    • For Technical Writing Role: InDesign, Electronic IFU (eIFU), Instructions for Use, Support of electronic IFU website
      Process Owner of at least one QS process.
    • Advocates for creation or change in procedures in own procedures and with complementary procedures owned by others, along with appropriate technical rationale to support recommended changes.
    • As regulations change and quality systems are merged/aligned, drives the revamp of, creation/refinement of department and quality system SOPs, Work Instructions, forms and templates that have considerable graphical content, testing for clarity and usability with targeted users.
    • Drives creation of training and communication materials that can be used by self or other staff to convey new or updated processes.
    • Regularly leads structured problem-solving initiatives to resolve complex technical issues and formulate plans with documentation within appropriate quality system documentation vehicle.
    • Contributes process improvements to and drives key areas of strategic programs that implement improved processes to reduce error rates.


    Optional:

    • Advanced knowledge of items outlined in the Optional Skills section with sufficient expertise to support 3D design of packaging components and interaction with Finite Element (FEA) experts for modeling.
    • Development of test suites and testing of website design changes according to User Requirements (URS) as well as tracking SW bugs.

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