Description

Role Description:Software Technical Writer, Software Quality Consultant, Computer System Validation, CSV, URS, FDS, SDS
Competencies:EIS : Medical Device & Regulations
Experience (Years):4-6
Essential Skills:Technical Document WriterTechnical Document Writer Consultant? In collaboration with the engineering team, authors, reviews, and updates, technical documentation related to equipment, controls, and software. Related technical documentation can be, life cycle documents such as: URS (User Requirement Specifications), FDS (Functional Detailed Specifications), SDS (Software Detailed Specifications), HDS (Hardware Detailed Specifications, Traceability Matrixes, Test Plans, Technical memos, etc.? Will support engineering functions for CR generation process.? Responsible for generating Architectural Diagrams, DATA flow diagrams, Network Diagrams, and System diagrams as well as detailed process maps, create template for troubleshooting, and training materials.? Ensure accuracy and consistency of the technical documentation. ? responsible for documentation routing for approval including submitting documents for approval in the quality management systems.? Responsible for managing technical document workflow for assigned projects.? Support controls engineering in producing, editing, reviewing test plans, test scripts, forms and other forms of documentation related to assigned projects.? Responsible for authoring technical training documents for existing or new systems.? Manufacturing and engineering teams to determine the requirements of the process and develop specifications for manufacturing functions, user interface, and quality control.
Desirable Skills:? In collaboration with the engineering team, authors, reviews, and updates, technical documentation related to equipment, controls, and software. Related technical documentation can be, life cycle documents such as: URS (User Requirement Specifications), FDS (Functional Detailed Specifications), SDS (Software Detailed Specifications), HDS (Hardware Detailed Specifications, Traceability Matrixes, Test Plans, Technical memos, etc.? Will support engineering functions for CR generation process.? Responsible for generating Architectural Diagrams, DATA flow diagrams, Network Diagrams, and System diagrams as well as detailed process maps, create template for troubleshooting, and training materials.? Ensure accuracy and consistency of the technical documentation. ? responsible for documentation routing for approval including submitting documents for approval in the quality management systems.? Responsible for managing technical document workflow for assigned projects.? support controls engineering in producing, editing, reviewing test plans, test scripts, forms and other forms of documentation related to assigned projects.? responsible for authoring technical training documents for existing or new systems.? Work with manufacturing and engineering teams to determine the requirements of the process and develop specifications for manufacturing functions, user interface, and quality control.? Strong leadership, coaching and teaching skills.? Demonstrated influencing skills and management abilities without people reporting. ? Excellent communication, interpersonal and organizational skills.? Excellent organizational, interpersonal, written and oral communication skills required. Bachelor?s degree in a technical program such as Engineering, Computer Science, or Software Engineering. Advanced coursework in technical systems or continued education in technical disciplines is a plus .Master?s degree preferred ? Engineering, Computer Science, Software Engineering

Key Skills
Education

Any Graduate

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