The Technical Writer will work directly with Corporate Engineering, Quality and Regulatory, and other cross-functional teams, to create, develop, plan, write and edit various technical documents.
Writes technical documents including, but not limited to: instructions for use, safety documents, administration guides, reference materials, installation guides, service manuals, training materials, marketing spec sheets, IFU inserts, engineering studies and product labels.
Researches, plans, writes, edits, and coordinates the development of required product literature in the appropriate timeframes for launch.
Researches products by reading and studying the product specification, interviewing subject matter experts, using prototype or demo hardware and software, and observing actual uses.
Acts as a liaison between the Industrial Designer and New Product Development team to develop instructions for use.
Develops and proofreads labeling text for all packaging components.
Identifies and implements labeling solutions for Company products.
May need to develop and manage schedules for new product development projects.
Coordinates copy review and approval with product team members.
Ensures that all instructional information (including warnings and precautions) is standard for each product line and consistent across product lines.
Defines deliverables for product release and provides outlines of the content with respect to the correct legal, regulatory, marketing and quality requirements.
Tracks the preparation and approval of product documents with the multiple departmental stakeholders.
Researches and translates technical information into manuals and/or other required documents for nontechnical and technical users.
Document engineering processes and specifications.
Recommends formats responsive to technical and customer requirements.
Ensures that all technical documents conform to the Company's documentation and quality assurance standards.
Organizes and facilitates team reviews & design reviews of deliverables of assigned projects.
Updates existing technical literature as required.
Maintains work instructions as needed and assigned.
Participated on product development team(s) and provides feedback about usability of product design and/or processes.
Manages language translations and works with outside translation services to provide language translations of all required technical communications and other required localized activities.
Other duties as assigned.
Must be able to travel up to 10% of the time; both domestic and International travel may be required.
Typical work related travel assignments range 2-5 days, and as such overnight, out-of-town stays are required.
Work Environment And Physical Demands
Typical office environment - accommodations will be evaluated where needed.
Minimum of 5 years of technical writing experience required.
Knowledge of Good Manufacturing Process (GMP), and ISO and FDA regulations required.
Experience writing for medical device industry strongly preferred.
Experience working in regulated industry strongly preferred.
Bachelor's Degree in Technical Communications, Technical Writing, Information Design, Marketing, Communication, Regulatory, English, Mechanical Engineering, or a related discipline required.
Certification in technical writing preferred, but not required.
Master's degree in a related field preferred, but not required.
General Skills/Competencies/Specialized Knowledge
Demonstrated success planning, developing, and executing complex technical documentation content.
Understanding of global publication translation processes.
Accuracy and attention to detail and quality.
Ability to gather information, analyze and develop tactical plan.
Ability to comprehend manufacturing processes, utilities and equipment.
Design Control - Knowledge in the application of design controls and development processes.
Technical Knowledge - Information design and technical writing with emphasis in developing engineering studies, protocols, technical specifications, product instruction booklets and manuals.
Computer Skills - Proficient computer system based tools including Microsoft Office applications (i.e., Word, Excel, PowerPoint, Outlook, etc.), e-mail, web browsers and spreadsheet software.
Product and Process Knowledge - Expected to develop an expert knowledge of our product lines and detailed knowledge of processes, procedures and regulations as they pertain to both new product development and sustaining engineering.
Communication - Expresses ideas clearly and simply both verbally and in writing. Promotes timely, ongoing flow of information to others and solves practical business problems. Communicates and listens effectively in order to develop and maintain key business relationships.
Interpersonal Skills - Ability to work with users of all levels. Ability to professionally interact and build constructive and effective relationships with all levels and functions within the Company. Ability to effectively interface with others on behalf of the organization. Able and willing to guide others in area of specialty.
Self-Directed - Ability to prioritize work, multi-task, solve problems and organize own time with minimal supervision. Ability to work well independently and exercise appropriate judgment under general direction. Ability to multi-task, completing concurrent projects within given time frames and managing interruptions and change requests. Takes initiative to learn by researching solutions and experimenting on the job, ability to transfer technical knowledge and expertise to technical and non-technical personnel. Takes initiative to establish new processes and methods to support a variety of coordination activities.
Collaboration and Teamwork - Ability to work well with other people to solve problems and to find the best solution. Ability to work effectively as part of a team. Works collaboratively and cooperatively with many teams cross-functionally. Energetic and willingness to work closely with all team members to achieve success. Negotiation and consensus building.
Teamwork - Works collaboratively and cooperatively with many teams cross-functionally. Energetic and willingness to work closely with all team members to achieve success. Drives accountability.
Adaptability - Embraces and adapts to change and demonstrates a willingness to learn. Reactionary and adaptable to abrupt changes, arising issues, extreme time pressures, and other exigent circumstances. Ability to identify urgent issues and respond accordingly. Acts as a change agent for the organization.
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