Engineering - Technical Writer - Exempt
About The Position
The Technical Writer develops medical device labeling for the Core Surgical/RST Business Units. Under general supervision, this role plans, researches, and writes labeling while managing deliverables as part of cross-functional project teams. The writer may simultaneously manage up to two labeling updates and one small new-product-introduction project involving multiple labeling pieces. The position is based primarily in North Haven, Connecticut, with onsite work four days per week and remote work one day per week. Applicants in Lafayette, Colorado, and Mounds View, Minnesota, are also considered. Candidates should note their location on their resume, and the commute should be under one hour. The employer seeks to hire and start candidates as soon as possible.
Requirements
- Strong collaboration skills.
- Strong verbal and written communication skills.
- Technical writing core competencies.
- Experience with authoring tools such as InDesign, FrameMaker, and XML tools.
- Experience in complex regulatory environments and robust quality processes.
Nice To Haves
- Five to ten years of relevant experience is preferred.
Responsibilities
- Plan, research, develop, and write medical device labeling.
- Manage labeling deliverables as part of cross-functional project teams under general supervision.
- Manage up to two labeling updates and one small new-product-introduction project involving multiple labeling pieces at the same time.
- Follow applicable quality management system documents and product commercialization procedures for labeling development.
- Interview users and technical staff to gather documentation information.
- Recommend formats that address technical and customer requirements.
- Assist with documentation for CAPAs and departmental and business-unit audits.
- Contribute 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 their status.
- Complete labeling proofs and develop documentation for regulatory submissions.
- Carry out other tasks as assigned.
Stand Out From the Crowd
Upload your resume and get instant feedback on how well it matches this job.
What This Job Offers
Job Type
Full-time
Education Level
No Education Listed
