Engineering - Technical Writer - Exempt

Join our team and contribute to the development of cutting-edge medical device labeling. This role is based in North Haven, CT, a vibrant location offering a balance of onsite collaboration and remote work flexibility.

• 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 in department and business-unit initiatives.
• Oversee the 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.

• 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.
• Requires a University Degree and a minimum of 5 years of relevant experience, or an advanced degree with 2 years of experience.

This role requires being onsite 4 days a week, with 1 day remote. Candidates should be located within a reasonable commuting distance to North Haven, CT, as onsite requirements cannot be changed. We are looking to hire and start as soon as possible.