Technical Writer - Product Development (Medical Device)

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.