Technical Writer

Redbock - an NES Fircroft company; North Haven (CT); Hybrid; USD 70,000 - 90,000; Full time

Job summary

Redbock - an NES Fircroft company is looking for an Engineering Technical Writer for a 12-month contract based in North Haven, CT. The job requires strong technical writing skills and collaboration with cross-functional teams.

The role involves updating Instructions for Use (IFUs), developing medical device labeling, and supporting project initiatives while adhering to regulatory standards. Candidates should have 5-10 years of experience in a technical writing role and be able to work onsite 4 days a week with some remote flexibility.

Qualifications

• 5-10 years of experience in technical writing, particularly in a medical or regulatory context.
• Strong understanding of quality processes and compliance standards.
• Proven ability to collaborate with cross-functional teams.

Responsibilities

• Update Instructions for Use (IFUs) in accordance with standards and feedback.
• Facilitate communication and approvals using PLM tools.
• Develop and write medical device labeling and documentation.
• Manage multiple labeling updates and new product introductions simultaneously.
• Conduct user interviews for data gathering and documentation.

Skills

Strong collaboration and communication

Technical writing competencies

Experience with authoring tools (InDesign, FrameMaker, XML)

Experience in regulatory environments

Job description

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

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

Top 3 Required Skills:

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

Primary Responsibilities

• 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.