Technical Documentation Specialist, Medical Devices

Position Overview

The Technical Writer role is an opportunity to build and maintain technical documentation infrastructure for a medical device company operating in a regulated environment. You will partner closely with teams to translate complex engineering and research concepts into clear and accurate documentation. Help to establish documentation standards, templates, and processes from the ground up while ensuring ongoing compliance with QMSR and ISO 13485 requirements.

Key Responsibilities

• Technical Documentation Development
  • Partner with teams to develop accurate technical documentation
  • Translate complex engineering and research concepts into clear, structured documentation for internal stakeholders across development, testing, research, and other functions
  • Ensure documentation accurately reflects real-world processes, system configurations, and operational use cases, updating rapidly in response to system changes and operational feedback
  • Identify gaps or inconsistencies and drive resolution proactively with relevant teams
  • Manage concurrent documentation efforts across multiple teams in a fast-paced, iterative environment
• Content Quality & Standards
  • Establish documentation standards, templates, and style guides from the ground up
  • Build and maintain version control processes across technical publications
  • Create and manage supporting visuals including system diagrams, process illustrations, and state machines
  • Review and edit content for accuracy, clarity, consistency, and adherence to program standards
• Regulated Environment Support
  • Ensure documentation aligns with applicable regulatory requirements including 21 CFR 820 and ISO 13485
  • Support verification and validation of technical publications for accuracy and compliance
  • Support internal and external audits including documentation preparation, recording of findings, and ensuring all materials are complete and audit-ready
  • Participate in the design of documentation reviews while maintaining primary accountability for delivery

Qualifications

Required

• Bachelor’s degree in Technical Communication, English, Engineering, Biomedical Science, or a related field
• 3+ years of technical writing experience in a regulated environment, preferably medical device or life sciences
• Working knowledge of 21 CFR 820 and ISO 13485 as they relate to documentation requirements
• Experience writing and maintaining technical documentation including SOPs, work instructions, and system documentation
• Demonstrated ability to translate complex engineering or scientific concepts into clear, structured content for internal audiences
• Strong written communication skills with the ability to produce accurate, audit-ready documentation
• Detail-oriented and organized with the ability to manage multiple concurrent documentation efforts

Preferred

• Familiarity with design controls and documentation structure within a regulated product development environment
• Exposure to eQMS platforms 
• Experience with version control systems and documentation management tools

 
 

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