Location: Newton, MA (Hybrid or 90% Remote - open to nearby states NH, VT, and ME)
Duration: 12-month Contract
Pay Rate: $65-$125/hour on W2 (negotiable depending on experience)
Hours: 9AM to 5PM
Summary:
We are seeking a Technical Writer to join our Endovascular Robotics business within Advanced Therapies. This role involves translating complex technical engineering processes and details into clear, accurate, and compliant documentation for a cutting-edge medical robotics system. We are a global technology leader in robotic-assisted vascular interventions. We believe the combination of endovascular robotics, image guidance and dedicated devices will change the way neurovascular procedures will be done in the future, enabling better outcomes, and enabling our customers to provide better access to care.
Responsibilities:
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, Microsoft Word) and content management systems.
Experience authoring IFU/operator manuals for highly complex medical devices.
Required skills:
Bachelor's degree in Engineering, Technical Communication, Life Sciences, or related field.
5-8 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.
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