Technical Writer

Description:

• Responsibilities: Author and maintain project-specific documents according to the regulations and standards for medical development and certification. These include, but are not limited to Design & Development Plans, Design Input/Design Trace Matrix, Software Development Plans, Risk Management Plans, Specifications, Test Methods, System Diagrams, Interaction Diagrams, Data Flows, Logical & Physical Architecture Diagrams, Design Verification Summary Reports, and Design Transfer documentation. Review the company’s and supplier’s documentation and provide expert judgment on how to most efficiently support the Design History File (DHFs). Collaborate with suppliers and Client functions to ensure appropriate documents are transferred or referenced appropriately in order to build compliant DHFs. Responsible for assessments of proposed changes related to project documentation. Author relevant technical sections of regulatory briefing books, submissions (CE, 510K), and other technical documentation as required. Participate in design review teams and in technical assessments.
• Qualifications & Requirements: BS, MS, or Ph.D. in Mechanical Engineering, Electrical Engineering, Biomedical Engineering, Computer Science, Physics, or related discipline. Excellent communication (written and verbal) skills are essential. At least ten years of hands-on experience in writing technical documents for the development of electromechanical devices. Experience with quality system documentation authoring is required. Working knowledge of worldwide medical device regulations, including 21 CFR 820, and ISO 13485, and how they apply to software and hardware development. Direct experience with IEC 62304, IEC 60601, and ISO 14971 is required.