Engineering - Technical Writer - Exempt

Lancesoft; North Haven (CT); Híbrido; USD 90.000 - 130.000; Jornada completa

Descripción de la vacante

Lancesoft in North Haven, CT is seeking a dedicated professional to join our Core Surgical/RST Business Units onsite 4 days a week with 1 day remote. You will plan, research, develop, and write medical device labeling as part of cross-functional teams.

The role requires strong collaboration and technical writing skills, experience with InDesign, Framemaker, and XML tools, and a track record in regulated environments.

Formación

• Strong collaboration, verbal/written communication skills, and technical writing core competencies.
• Experience with authoring tools such as InDesign, Framemaker, and XML tools.

Responsabilidades

• Plan, research, develop, and write medical device labeling for cross-functional project teams.
• Manage up to two labeling updates and one small new-product-introduction project.
• Coordinate translations and oversee ECN process for labeling.
• Prepare documentation for regulatory submissions and support audits.
• Contribute to time and cost estimates for labeling deliverables.
• Develop illustrations with professional illustrators.

Conocimientos

Collaboration

Verbal/Written communication

Technical writing

Herramientas

InDesign

FrameMaker

XML tools

Descripción del empleo

Join our dynamic team in North Haven, CT, a vibrant community known for its rich history and excellent quality of life. We are seeking a dedicated professional to contribute to our Core Surgical/RST Business Units. This role requires being onsite 4 days a week with 1 day remote, offering a great balance of collaboration and flexibility.

Key Responsibilities

Plan, research, develop, and write medical device labeling, managing 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 involving 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.

Required Skills and Experience

Strong collaboration, verbal/written communication skills, and technical writing core competencies. Experience with various authoring tools (e.G., InDesign, Framemaker, XML tools). Experience in complex regulatory environments and robust quality processes. 5-10 years of relevant experience is preferred.

Additional Information

This position is prioritized for our North Haven, CT location, but we are also open to applicants in Lafayette, CO, and Mounds View, MN. Please ensure your location is noted on the resume, as the commute should be under one hour. We are looking to hire and start candidates as soon as possible.