The Ortho R&D Technical Writer is responsible for creating, editing, and maintaining high-quality documentation that supports regulatory compliance and product usability. This includes Instructions for Use (IFU), user manuals, labeling content, and technical specifications for medical devices.
Key Responsibilities:- Develop and maintain technical documentation in compliance with FDA, ISO 13485, and other regulatory standards, ensuring accuracy and completeness.
- Create detailed user manuals including step-by-step instructions, diagrams, and troubleshooting guides for healthcare professionals and patients.
- Collaborate with engineers to interpret CAD drawings and technical specifications for accurate documentation.
- Ensure all documentation meets readability standards for diverse audiences and complies with global regulatory requirements.
- Perform gap analysis on existing documentation and implement improvements for clarity and compliance.
- Coordinate with regulatory teams to prepare submission-ready documents for FDA and EU MDR approvals.
- Maintain document templates and style guides to ensure consistency across all product lines.
- Conduct peer reviews and validation checks to guarantee technical accuracy and usability.
- Manage document revisions and version control within PLM systems (e.g., Windchill).
Qualifications:- Bachelor's degree in Communications, Engineering, Life Sciences, or related field.
- 5+ years of experience in technical writing within the medical device or regulated industry.
Preferred Qualifications:- Strong knowledge of regulatory requirements (FDA, MDR, ISO).
- Proficiency in document control systems and tools (Windchill preferred).
- Excellent written and verbal communication skills
Expected Travel 0-20%
This position is not eligible for employer-visa sponsorshipThis job posting is anticipated to close on June 19, 2026. We may, however, extend this time period, in which case the posting will remain available on careers.conmed.com. Please submit your application as soon as possible as we will be reviewing applications on a rolling basis as we receive them.
Benefits:CONMED offers a wide array of benefits to fit your unique needs. Visit our Benefits Page for more information.
- Competitive compensation
- Excellent healthcare including medical, dental, vision and prescription coverage
- Short & long term disability plus life insurance -- cost paid fully by CONMED
- Retirement Savings Plan (401K) -- CONMED matches your contributions dollar for dollar, with the potential for up to 7% per pay period
- Employee Stock Purchase Plan -- allows stock purchases at discounted price
- Tuition assistance for undergraduate and graduate level courses
Know someone at CONMED? Have them submit you as a referral before applying for this position to be eligible for our Employee Referral Program incentives!
