Job Description
Job Description
Position Type:
- Contract
- Hybrid
Required:
- Bachelor’s degree in Engineering, Technical Communication, Life Sciences, or related field.
- 8+ years of experience in technical writing, preferably in medical devices or regulated industries.
- Strong attention to detail, organization, and ability to manage multiple projects.
- Excellent written and verbal communication skills.
- Experience writing or leading creation of user guides for complex electromechanical or software-based medical devices.
- Ability to work independently.
- Familiarity with tools such as:
-
- Adobe FrameMaker
- MadCap Flare
- Microsoft Word
Nice-to-Have Skills:
- Experience with robotic systems.
- Experience developing training materials.
Collaboration:
- Will work closely with:
- Systems Engineering
- Product Management
- Usability Teams
Responsibilities:
- Translating complex technical engineering processes and details into clear, accurate, and compliant documentation for a cutting-edge medical robotics system.
- Author and revise IFUs, operator manuals, installation manuals, service manuals, and quick reference guides in accordance with FDA, MDR, and ISO standards.
- Translate complex engineering concepts into clear, concise, and accessible documentation for clinical and technical audiences.
- Collaborate with cross-functional teams (engineering, regulatory, human factors, QA) to gather source material and verify/validate content.
- Maintain version control and traceability of documentation.
- Support risk management and design history file (DHF) documentation as needed.
- Assist in developing templates, style guides, and documentation standards.
- Familiarity with usability testing, risk management, and regulatory documentation (FDA 21 CFR Part 820, ISO 13485).
- Experience with authoring tools (e.g., Adobe FrameMaker, MadCap Flare, and MS Word) and content management systems.
- Experience authoring IFU/operator manuals for highly complex medical devices.
Company DescriptionHired by Matrix believes in the human touch and starts every partnership with an in-depth conversation. By talking with our clients about their hiring needs and listening to job seekers describe their career goals, we build an understanding of what they are looking for and work hard to make it happen.
Company Description
Hired by Matrix believes in the human touch and starts every partnership with an in-depth conversation. By talking with our clients about their hiring needs and listening to job seekers describe their career goals, we build an understanding of what they are looking for and work hard to make it happen.