Technical Writer

Horizontal Integration Minneapolis, MN 55416 2017-03-08
*background & drug check required

POSITION DESCRIPTION:
This position is responsible for planning, research, and technical writing support
for medical device industry product labeling within CVG Technical
Communication.
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POSITION RESPONSIBILITIES:
• Technical writer who provides labeling support to product development
teams, including:
o Able to translate complex product information into concise,
compliant, easy-to-follow instructions for use.
o Broad understanding of the impact of language localization and its
effect on English content.
o Intermediate understanding of project management, including
development and maintenance of work breakdown structure,
project schedule, and milestones.
o Work with more senior writers to identify and mitigate
assumptions, dependencies, and risks related to IFU development
and implementation.
o Successfully negotiate project schedules and implementation
plans to support the labeling process.
o Acquire subject knowledge by interviewing writers, product
developers, regulatory, quality, and marketing personnel, and by
referring to the product, technical specifications, and engineering
illustrations and trade journals.
o Manage stakeholder input and negotiate content development
strategy for product development and sustaining engineering
projects.
o Basic understanding in how regulations, laws, standards, product
specifications, and internal procedures impact IFU design.
o Respond to new or changed user requirements by planning
changes or improvements to IFU content.
o Influence product implementation plan through labeling
architecture and electronic labeling strategy.
o Coordinate IFU translations through internal or external sources.
o Coordinate the review and approval of technical documents for a
project team in enterprise configuration management systems.
o Maintain necessary records for project tracking and
legal/regulatory requirements.
• Provide technical direction and mentoring to more junior technical writers.
• Work with translation partners to broaden the business’ understanding of
content localization and the need for well-written global English content.
• Understanding of Medtronic’s quality system and how it impacts product
labeling.
• May participate in implementation of department projects.
o Provide input to new procedures to implement process
improvement initiatives.
o Contribute to special initiatives, consistent with organizational
objectives.
o Apply creativity and innovation to solve problems related systems,
processes, and tools.
o Collaborate with business partners inside and outside of Technical
Communication to participate in projects and to set the direction
for future projects.
• Engage in development and establishment of industry trends in technical
communication, information architecture, and/or content management.
Uses this expertise to help Medtronic maintain its position as an industry
leader in innovation.
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BASIC QUALIFICATIONS:
• Technical writing experience
• Proven application of project management tools
• Experience working with cross-functional project teams
• Working knowledge of software technologies used for writing, publishing,
and document control.
• Understanding of product labeling development in a regulated industry.

EDUCATION REQUIRED:
• BA/BS
YEARS OF EXPERIENCE:
• 2+ years of experience in technical writing with a Masters’ degree
• 3+ years of experience in technical writing with a BA/BS degree
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DESIRED/PREFERRED QUALIFICATIONS:
• Understanding of the following topics:
o ISO regulations, FDA QAR design controls, Good Manufacturing
Process (GMP), etc.
o User experience principles
Last Updated: 2/28/2017
o Authoring in XML in a single-source content development
environment
o Ability to work effectively across disciplines to implement creative
solutions to complex problems
o Writing for a global audience
• Ability to manage multiple projects
• Ability to learn and adapt to changes in technology, processes, and
requirements
• Strong attention to detail and accuracy
• Ability to evaluate audience and effectively communicate the appropriate
level of detail
• Ability to work independently and make sound decisions
• Ability to take direction
• Ability to give and receive constructive feedback
• Excellent problem-solving skills