Job Description

Engineering- Technical Writer (12 month contract // Lafayette, CO):

A leading medical device company is seeking an Engineering Technical Writer to work onsite 3 days/week in Lafayette, CO.

Primary activities of this role will be updating IFUs, user manuals, and product documents delivered with the docs in hard copy or online. This will include gathering inputs/requirements from the Engineering/PM/Regulatory/Quality teams, making updates to the documents in the client’s authoring tools (primarily InDesign, FrameMaker, and other XML based systems, like Vasont, Oxygen, MadCap Flare), processing change orders through the client’s PLM (Agile), requesting translations from supplier, gathering data for electronic release (e-manuals), and acquiring print proofs

Top 3 Required Skills:

1. Strong collaboration and verbal/written communication skills.
2. Experience with various authoring tools (ex. InDesign, FrameMaker, XML tools).
3. Experience in complex regulatory environments and robust quality processes.

Primary Responsibilities:

• Update product manuals 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 translations 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 product manuals from planning through launch.

Target Years of Experience: 2-5 years of experience with technical communications and technical writing

Duties:

• 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.
• Conducts interviews with various users and technical staff to gather data for documentation.
• Recommends 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.

Must Have:

• Adobe FrameMaker or other professional publishing tools
• Expert knowledge of Adobe Creative Cloud – InDesign, Illustrator, and Photoshop.
• Strong document writer and reviewer with demonstrated experience

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