What are the responsibilities and job description for the Engineering Documentation Expert position at katalyst HLS?
Key Responsibilities:
- 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.
Required Qualifications:
- 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.
Job Type: Full-time
Pay: Up to $33.00 per hour
Expected hours: 40 per week
Schedule:
- Day shift
Work Location: In person
Salary : $33
