Documentation Specialist for Medical Devices

hace 7 días


Tijuana, Baja California, México Outset Medical A tiempo completo

Outset Medical is seeking a skilled Documentation Specialist to join our team. This role will be responsible for developing technical documentation strategy and content for our novel dialysis machine and supporting products.

Key Responsibilities

  • Create and maintain technical documentation for medical devices, including user manuals, instructions for use (IFUs), and service manuals
  • Collaborate with cross-functional teams including engineers, regulatory affairs, and quality assurance to gather information and ensure accuracy of documentation
  • Translate technical specifications and data into clear, concise, and user-friendly content
  • Evaluate and revise documentation based on feedback from stakeholders and users
  • Manage documentation version control and updates throughout product lifecycle
  • Assist in the creation of training materials and presentations for internal and external stakeholders

Requirements

  • Bachelor's degree in technical writing, English, communications, Engineering or a related field
  • Strong writing skills with the ability to convey complex technical information clearly and concisely
  • Experience in technical writing, preferably in the medical device or healthcare industry
  • Knowledge of medical device regulations and standards (e.g., FDA regulations, ISO 13485)
  • Ability to understand and interpret technical specifications and engineering documents

About Outset Medical

At Outset Medical, we're revolutionizing an industry and changing lives. We're impacting what the future of dialysis looks like by creating a first-of-its-kind technology in order to reduce the cost and complexity of dialysis. Our focus is to create one high performing team, obsessed with progress, in an atmosphere that is brimming with transformative opportunities.

Estimated salary: $80,000 - $110,000 per year, depending on experience and qualifications.


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