Job Description

Job Title: Engineering – Technical Writer

Location: North Haven, CT | Lafayette, CO | Mounds View, MN

Duration: 12 months

Job Summary

We are seeking an experienced Technical Writer to develop, update, and manage medical device labeling and Instructions for Use (IFUs). The ideal candidate will have strong technical writing skills, experience with authoring tools, and knowledge of regulated medical device environments and quality processes.

Key Responsibilities

• Develop, review, and update medical device labeling and Instructions for Use (IFUs).
• Collaborate with Engineering, Regulatory, Quality, and cross-functional teams to ensure documentation accuracy and compliance with applicable standards.
• Manage labeling updates and documentation for new product introductions.
• Use authoring tools such as Adobe InDesign, FrameMaker, and XML tools.
• Manage labeling approvals through PLM systems and support Engineering Change Orders (ECOs).
• Coordinate translation requests, track progress, review print proofs, and support electronic and hardcopy labeling releases.
• Support regulatory submissions, CAPA documentation, audits, and quality management processes.
• Participate in project meetings and manage labeling deliverables, timelines, and launch activities.

Required Skills

• 5+ years of technical writing experience, preferably in the medical device industry.
• Experience developing medical device labeling and Instructions for Use (IFUs).
• Proficiency with Adobe InDesign, FrameMaker, XML, or similar authoring tools.
• Knowledge of regulatory requirements, quality management systems, and document control processes.
• Experience with PLM systems, Engineering Change Orders, and translation management is preferred.
• Excellent written communication, verbal communication, collaboration, and organizational skills.
• Ability to manage multiple projects and meet deadlines.

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