Technical Writer

Engineering Technical Writer (12 month contract // North Haven, CT)

onsite 4 days/week (1 day remote) (open to Boulder, CO or Minnesota locations)

• Strong collaboration and verbal/written communication skills and technical writing core competencies.
• Experience with various authoring tools (i.e., InDesign, Frame Maker, and XML tools).
• Experience in complex regulatory environments and robust quality processes.

• Update Instructions for Use (IFUs) to align with cross‑functional feedback, standards compliance, and other inputs in alignment with Tech Comm and business quality processes.
• Support approvals in PLM tools, facilitate translation requests, and support launch activities (electronic and hardcopy distribution activities, such as metadata information and print proofs).
• Participate in project and team meetings, and collaborate with teams to create, analyze, and finalize Instructions for Use (IFUs) from planning through launch.
• Plan, research, develop, and write medical device labeling, and manage labeling deliverables as part of cross‑functional project teams under general supervision.
• Simultaneously manage up to two labeling updates and one small, new‑product introduction project that involves multiple labeling pieces.
• Understand and adhere to all quality management system documents and product commercialization procedures applicable to labeling development.
• Conduct interviews with various users and technical staff to gather data for documentation.
• Recommend formats responsive to technical and customer requirements.
• Assist in providing documentation for CAPAs, and departmental and business‑unit audits.
• Contribute to time and cost estimates for labeling deliverables for project teams.
• Develop illustrations in cooperation with professional illustrators.
• Participate on department and business‑unit initiatives.
• Oversee Engineering Change Order process for labeling.
• Coordinate translations and track the status of translations.
• Complete labeling proofs, develop documentation for regulatory submissions, and carry out other tasks as assigned.

Target Years of

Experience:

5-10 years.