Post Market Surveillance Specialist – Technical Writing

Primary Function of Position:

The Post Market Surveillance Specialist – Technical Writing provides feedback to customers via Failure Analysis Letters. Feedback includes a summary of failure analysis results, Instruction For Use (IFU) reminders, and recommendations for customer consideration. Failure analysis letters can be written for all Intuitive products and platforms including the daVinci robotic assisted surgery system and Ion robotic assisted bronchoscopy system

Roles and Responsibilities:

This position has responsibility and authority for:

• Creation and distribution of failure analysis letters based on completed failure analysis results
• Managing failure analysis letters and backlog using software systems such as SAP and Trackwise
• Work with translation vendors, as required, for letters outside of US
• Provide clarification on failure analysis letter content when requested
• Escalate feedback, comments, or concerns from customers or distributors based on failure analysis letters provided to end user
• Escalate complaints to the Post Market Investigation (PMI) group as required
• Interface with Failure Analysis, Customer Service, engineering, RMA, and clinical teams to gather information required for failure analysis letter content
• Maintain library of similar responses in reference to failure modes, root cause, IFU reminders, and recommendations
• Participate in process improvement activities to continuously improve process effectiveness
• Execute on projects as required
• Perform other duties as directed