Technical Writer, Contract
Job Description
REQUIREMENTS
- 5+ years of professional technical writing experience, with a portfolio demonstrating user manuals and safety documentation.
- Direct experience with medical devices (Class I or II), consumer electronics, or wellness/fitness technology products.
- Familiarity supporting documentation within regulated product environments, including FDA, IEC, UL, EU MDR, and/or CE marking requirements.
- Familiarity with ISO 14971 (risk management), IEC 62366 (usability engineering), and ANSI Z535 / ISO 7010 safety symbology.
- Proficiency in structured authoring tools (e.g., MadCap Flare, Adobe FrameMaker, Oxygen XML).
- Experience with content management systems, version control, and single-source publishing workflows.
- Exceptional written English with the ability to simplify highly technical concepts for consumer audiences.
- Strong project management skills with the ability to manage multiple product lines and deadlines simultaneously.
Preferred
- Bachelor’s degree in Technical Communication, English or a related field.
- STC (Society for Technical Communication) certification or equivalent professional credential.
- Experience writing documentation for Bluetooth/app-connected hardware devices.
- Previous experience in a contract or consulting capacity, working across multiple product launches simultaneously.
RESPONSIBILITIES
Product User Manuals
- Create and maintain documentation content including user manuals, quick-start guides, safety inserts, warning labels, packaging copy, and troubleshooting materials.
- Author, revise, and maintain user manuals for all our client’s devices including but not limited to percussive therapy, heating and cooling, pneumatic compression, light therapy, and electrical stimulation devices.
- Collaborate with mechanical, electrical, and firmware engineering teams to ensure technical accuracy of all product documentation.
- Collaborate with product management, marketing, and legal to ensure compliance and maintain brand standards.
- Develop clear assembly, setup, operation, maintenance, and troubleshooting instructions with supporting illustrations and diagrams.
- Create structured templates to ensure consistency across the full product catalog.
Safety & Compliance Documentation
- Write and maintain unit warnings, caution statements, and safety notices in compliance with applicable regulatory standards (UL, IEC 62368-1, IEC 60601 where applicable, FDA Class I/II guidance).
- Develop risk-communication language aligned with ISO 14971 risk management outputs.
- Ensure all safety symbols, signal words, and hazard statements conform to ISO 7010, ANSI Z535, and regional market requirements.
- Partner with Regulatory Affairs and Quality Assurance teams to incorporate compliance feedback into documentation revisions.
- Support documentation review and approval workflows across engineering, regulatory, legal, and quality teams.
Localization & Global Readiness
- Prepare documentation for multi-language localization, working with internal translation partners to ensure accuracy and cultural appropriateness.
- Maintain region-specific versions of manuals to address EU, UK, APAC, and other international regulatory requirements.
- Manage documentation updates, version control, and change tracking across product generations, firmware releases, and regulatory revisions.
- Maintain organized source documents, revision histories, and approval tracking across product releases and regional variants.
Cross-Functional Collaboration
Deliver finalized, approval-ready copy documents to artwork and packaging teams for production layout and localization workflows.
- Work closely with Design and Brand teams to ensure documentation aligns with our client’s premium aesthetic and tone of voice.
- Participate in design reviews and product launch readiness milestones to ensure documentation is delivered on time.
Are you interested in this position?
Apply by clicking on the “Apply Now” button below!
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