We're looking for a Technical Writer to help turn complex technical and scientific information into clear, well-structured documentation. From SOPs and test methods to IFUs and technical reports, you'll play a key role in making sure our products are accurately documented and ready for market.
Essential Functions:- Collaborates with Research & Development, Manufacturing and Marketing teams to accurately document test methods, technical reports, labels, and other design file documents for specific market products.
- Performs independent literature research, analyzes data and conducts interviews for in-depth white papers and other scientific/technical documents.
- Conducts extensive literature and industry research, analyzes results and compiles information into meaningful reports for various audience types.
- Performs interviews with scientific and technical staff, and translates information onto detailed documents.
- Creates all essential documentation for technical device design histories, manufacturing BOMs and routers.
- Works closely with regulatory and quality staff to ensure product documentation supports regulatory and quality standards.
- Works with project and product managers to document product alignment with business strategy.
- Designs and creates protocols, technical reports, test methods, manufacturing instructions, project planning documents and labeling documents.
- Designs marketing documents, IFUs and labels according to the Quality System.
- Supports project managers with action items, project planning documentation, and coordinates with the project team for successful launch of product.
- Creates Standard Operating Procedures (SOPs) for new procedures; maintains and updates current SOPs.
- Creates technical submission files and coordinates with regulatory team on submission/approval process.
- Collaborates with regulatory team to assist with international submissions; creates additional required documents as new regulations arise in different countries.
- Coordinates, validates, and assists with documenting test results.
- Performs other related duties and projects as business needs require at direction of management.
Minimum Qualifications:
- Bachelor's Degree in Engineering, Science or a related technical field.
- Minimum of four (4) years of direct documentation experience in the medical device, software or other technical industry.
- Knowledge of 21 CFR 820.
- Knowledge of current US and International regulations as it pertains to documentation.
- Knowledge of current US and International standards governing medical devices.
Pay range: $30.00 to $43.00/hr
Exact compensation may vary based on skills and experience.
This role is fully onsite at our Irvine, CA campus. Remote or hybrid arrangements are not available.
Employment Type: full-time