BioTalent Contract Technical Writer i

SUMMARY Our client is seeking an Engineering Technical Writer responsible for developing documentation that supports FDA and MDR regulatory submissions while meeting their quality system requirements. This role will create engineering documentation related to programming, systems operation, and user interfaces.

 

The position requires close collaboration with cross-functional teams and a solid understanding of medical device design processes.

 

ESSENTIAL DUTIES

• Create and edit technical content in partnership with engineering teams to develop project requirements, design specifications, and risk management documentation
• Update engineering documentation based on SME feedback, including cybersecurity documentation, software development materials, and verification/validation plans
• Gather technical information from subject matter experts to develop procedure manuals, specifications, and process documentation

 

QUALIFICATIONS

• Excellent technical writing and documentation skills
• Strong organizational and communication abilities
• Knowledge of medical device development documentation requirements
• Understanding of software development and testing principles
• Collaborative team player with attention to detail
• Self-motivated with ability to work independently
• Proactive problem-solver with thorough task completion