Description

You will author and manage technical documentation for equipment, controls, and software within a regulated medical device environment.

Responsibilities

• Author, review, and update lifecycle documents including URS, FDS, SDS, HDS, Traceability Matrixes, and Test Plans.
• Generate architectural, data flow, network, and system diagrams alongside detailed process maps.
• Manage technical document workflows and routing for approval within quality management systems.
• Support controls engineering by producing and editing test plans, test scripts, and troubleshooting templates.
• Collaborate with manufacturing and engineering teams to develop specifications for user interfaces and quality control.

Required Skills

• 4-6 years of experience in technical document writing and software quality consulting.
• Experience with Computer System Validation (CSV) and medical device regulations.
• Proficiency in generating Architectural Diagrams, Data Flow Diagrams, and Network Diagrams.
• Ability to manage Change Request (CR) generation processes.
• Experience authoring technical training materials and system documentation.
• Bachelor's degree in a technical program such as Engineering, Computer Science, or Software Engineering.

Preferred Skills

• Master's degree in Engineering, Computer Science, or Software Engineering.
• Advanced coursework in technical systems.

Key Skills

Education

Any Graduate