Engineering Technical Writer

We are seeking an experienced Technical Writer / Labeling Specialist to support labeling development for medical devices. This individual will work cross-functionally to develop, update, and manage Instructions for Use (IFUs) and other labeling deliverables in compliance with regulatory standards and quality processes.

• Strong collaboration, and excellent verbal and written communication skills (including technical writing).
• Proficiency with authoring tools (e.g., Adobe InDesign, FrameMaker, XML tools).
• Experience working in complex regulatory environments with robust quality systems.

• Update and maintain Instructions for Use (IFUs) to align with cross-functional feedback, regulatory requirements, and quality standards.
• Support PLM workflows , including approvals, translation coordination, and product launch activities (metadata management, print proofs, and distribution).
• Collaborate with cross-functional teams to plan, develop, review, and finalize labeling from concept through product launch.

• Plan, research, develop, and write medical device labeling content.
• Manage multiple projects simultaneously (e.g., labeling updates and new product introductions).
• Ensure compliance with Quality Management Systems (QMS) and product commercialization processes.
• Conduct interviews with technical staff and stakeholders to gather documentation requirements.
• Support Engineering Change Orders (ECOs) related to labeling.
• Coordinate and track translation activities.
• Develop documentation for regulatory submissions and audits (including CAPAs).
• Collaborate with illustrators to develop supporting visuals and diagrams.
• Contribute to project timelines and cost estimates.
• Participate in department and cross-functional initiatives.

• Bachelor's degree required.
• 5-10 years of relevant experience in technical writing, preferably in medical devices or regulated industries.
• Strong understanding of regulatory documentation and labeling requirements.
• Demonstrated ability to manage multiple projects and deadlines.
• Experience working within PLM systems and quality/regulatory processes.