Develop comprehensive technical documentation, including user manuals, installation guides, labeling materials, and regulatory documentation for ophthalmic devices.
Work closely with engineering, regulatory, and quality teams to ensure all documentation meets industry standards and regulatory requirements.
Interpret engineering drawings and specifications to create detailed build and qualification procedures for complex ophthalmic systems.
Collaborate with R&D and manufacturing teams to understand system design and develop documentation accordingly.
Ensure all documentation complies with FDA, ISO 13485, and other medical device regulatory standards.
Review and update documentation throughout the product development lifecycle, incorporating feedback from engineers, technicians, and end-users.
Develop standard operating procedures (SOPs) and best practices for documentation within the organization.
Support training efforts by creating easy-to-follow instructions for assembly, testing, and troubleshooting of ophthalmic systems.
Requirement:
Experience in technical writing/documentation for medical devices, particularly in the ophthalmic domain.
Mechanical engineering background with the ability to interpret engineering drawings and system schematics.
Knowledge of medical device labeling regulations and compliance requirements.
Experience with build procedures and qualification processes for complex systems.
Familiarity with FDA, ISO 13485, and other medical device regulations.
Strong communication skills with the ability to translate technical information into clear, user-friendly documentation.
Proficiency in technical documentation tools such as Adobe FrameMaker, MadCap Flare, MS Word, or similar.
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