Technical Writer II
Why Join ACIST?
We care as much about our employees as we do our patients. Our culture fosters a work environment where employees can thrive, be passionate and have fun along the way. Each member of the ACIST team has the power to make a difference......every day!
The Technical Writer II role will research, plan, organize, write, review, and publish technical product literature (such as user’s guides, quick guides, instructions for use (IFUs), and product labels) by working closely with Engineering (software, electrical, mechanical, systems), Project and Program Management, Regulatory Affairs, Design Assurance, Quality, Training, Marketing, and Legal departments. This role will also be responsible for managing translations of technical product literature, working with software engineers to localize software and developing and managing translation reference materials (glossaries, etc.) to aid the translation process. The customers and clients for this technical literature include physicians, nurses, and hospital technicians, as well as ACIST sales, marketing, and technical support personnel.
Primary Duties and Responsibilities:
Develop and maintain technical product literature:
- Research products by studying the product specifications, interviewing subject matter experts, using prototype hardware and software.
- Research, write, and edit, product literature in the appropriate timeframe and in compliance with company operating procedures and work instructions.
- Ensure that product literature is consistent, clear, technically accurate, complete, and meets regulatory, marketing, and branding requirements.
- Incorporate human factors and usability analysis to improve document readability and safe use of products.
- Commit to a scheduled completion date. Inform management if schedule requires adjustment.
- Support Technical Writer I employees to aid them in understanding the work, company policies, and quality system, regulatory, and labeling requirements.
- Support project teams by developing, communicating, and maintaining project schedules.
- Create and modify localized screen captures .
- Organize and facilitate content and quality reviews of product literature.
- Edit documents, making technically and stylistically appropriate modifications.
- Manage the change order release of product literature using Agile.
- Update existing technical literature and labels as required.
- Assist in the maintenance of internal systems and procedures to ensure consistency of format, style, clarity, safety, and technical accuracy.
- Coordinate projects with outside vendors such as illustrators, photographers, and printers.
- Peer review documents produced by other writers.
- Create UDI-compliant barcodes using Bartender.Other projects as assigned.
- Other projects as assigned.
Manage language translations of literature and localized software user interface:
- Define deliverables according to geographical requirements.
- Work with translation service providers for all localization activities.
- Establish and maintain translated glossaries and style guides.
- Manage linguistic validations of software GUI.
Qualifications (Knowledge, Skills & Abilities):
- BS or BA degree in Technical Writing, English, Communications, or a technical field with coursework in technical writing.
- Previous technical writing experience in the medical device industry (3 years minimum).
- Demonstrated ability to write clearly and concisely.
- Intermediate level at using InDesign in creation of printed and electronic documents.
- Intermediate level use of Bartender, Illustrator, Photoshop, and Acrobat.
- Knowledge of global medical device regulations and international standards as they relate to labeling requirements.
- Experience using Agile software.
- Experience with translation projects.
- Experience working with complex hardware and software systems and engineering teams.
- Aptitude for new technologies and tools.
- Experience with managing vendor relationships.
- Demonstrated ability to manage multiple projects, sometimes with short or changing deadlines.
- Excellent people and communication skills.
- Excellent organizational skills.
- Attention to detail.
- Project management experience.
- Experience in medical technology and/or software end-user documentation.
- Familiarity with electronic delivery on websites and CD.
- General knowledge of the printing process and preparing documents for print.
- SGML, HTML, or XML authoring experience.
- Mental demands – work is detail oriented, often with multiple priorities. The environment is deadline sensitive and the employee may be exposed to high-pressure situations.
- Travel requirements are minimal (less than 5%).