Design Control Engineer 3 Job at Intuitive Surgical, Sunnyvale, CA

  • Intuitive Surgical
  • Sunnyvale, CA

Job Description

Design Control Engineer 3 at Intuitive Surgical supports medical device product development through design control documentation, regulatory compliance, and team training. The role involves coaching engineering teams on quality processes, developing training content, and maintaining design history files in an ISO 13485 environment.

Responsibilities

  • Mentor development and manufacturing teams on design controls, risk analysis, and process tools
  • Develop and deliver training content across multiple formats including online modules and instructor-led sessions
  • Support design teams through ticket-based requests and complex documentation guidance
  • Standardize design control documents and ensure Good Documentation Practices compliance
  • Compile and maintain Design History Files including risk analyses, requirements, and validation documentation

Requirements

  • Bachelor's degree in engineering, science, or technical field
  • Minimum 3 years technical experience; medical device industry preferred
  • Knowledge of ISO 14971, ISO 13485, and FDA 21 CFR Part 820 standards
  • Experience with regulated product development and design control documentation
  • Proficiency with Agile/PLM systems and Polarion or similar requirements management tools
  • Experience with Learning Management Systems (LMS)

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