Technical Writer - Med Device
Daley And Associates, LLC, Boston, MA, United States
Technical Writer (Medical Device) - Boston, MA
We are seeking a Technical Writer (Medical Device) to join a global medical technology company in Boston, MA. This role is responsible for developing, updating, and maintaining technical content, producing multi‑channel outputs with a strong focus on PDF publishing, and collaborating with cross‑functional teams. The ideal candidate will have 4+ years of experience in technical writing, content management, and digital publishing within the medical device industry, along with hands‑on expertise using MadCap Flare.
This is a 6+ month contract position that will pay $40-45/hr (depending on experience) within a 40‑hour workweek. This position offers a hybrid work model, onsite 3 days per week and remote 2 days.
Responsibilities: Create and manage technical documentation using MadCap Flare, utilizing condition tags, variables, snippets, content reuse strategies, and multichannel publishing outputs (with a focus on PDF publishing).
Develop, update, and maintain product documentation, including reference guides, user manuals, instructions for use (IFUs), and package inserts.
Support design control processes to ensure documentation is accurate, compliant, and completed promptly.
Review design inputs/outputs, risk management files, and verification/validation documentation to ensure alignment with IFU content.
Ensure all documentation complies with applicable global labeling and regulatory requirements.
Process documentation updates through formal engineering change control (ECO) procedures.
Maintain consistency across documentation sets and product families.
Contribute to process improvements related to style guides, templates, and publishing workflows.
Collaborate cross‑functionally with Marketing, Regulatory Affairs, Quality, and Engineering to ensure documentation reflects product requirements.
Provide additional documentation and project support as needed.
Qualifications Bachelor’s degree in English, Writing, Marketing, Communications, or a related field.
4 – 5+ years of technical writing, content management, or digital publishing experience, preferably within the medical device industry.
Familiarity with global labeling regulations such as the FDA, EU MDR, IVDR, and Health Canada.
Strong proficiency with MadCap Flare as a CMS and technical documentation tool.
Experience working within a Quality Management System (QMS) environment.
Experience with Adobe Acrobat and Adobe FrameMaker; Smartsheet experience is a plus.
Strong understanding of structured documentation, document lifecycle management, and version control.
Experience working in a highly regulated environment with strict compliance requirements.
Excellent written and verbal communication skills with strong attention to detail.
Highly organized with the ability to manage multiple priorities in a fast‑paced environment.
Ability to work both independently and collaboratively to deliver high‑quality documentation.
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This is a 6+ month contract position that will pay $40-45/hr (depending on experience) within a 40‑hour workweek. This position offers a hybrid work model, onsite 3 days per week and remote 2 days.
Responsibilities: Create and manage technical documentation using MadCap Flare, utilizing condition tags, variables, snippets, content reuse strategies, and multichannel publishing outputs (with a focus on PDF publishing).
Develop, update, and maintain product documentation, including reference guides, user manuals, instructions for use (IFUs), and package inserts.
Support design control processes to ensure documentation is accurate, compliant, and completed promptly.
Review design inputs/outputs, risk management files, and verification/validation documentation to ensure alignment with IFU content.
Ensure all documentation complies with applicable global labeling and regulatory requirements.
Process documentation updates through formal engineering change control (ECO) procedures.
Maintain consistency across documentation sets and product families.
Contribute to process improvements related to style guides, templates, and publishing workflows.
Collaborate cross‑functionally with Marketing, Regulatory Affairs, Quality, and Engineering to ensure documentation reflects product requirements.
Provide additional documentation and project support as needed.
Qualifications Bachelor’s degree in English, Writing, Marketing, Communications, or a related field.
4 – 5+ years of technical writing, content management, or digital publishing experience, preferably within the medical device industry.
Familiarity with global labeling regulations such as the FDA, EU MDR, IVDR, and Health Canada.
Strong proficiency with MadCap Flare as a CMS and technical documentation tool.
Experience working within a Quality Management System (QMS) environment.
Experience with Adobe Acrobat and Adobe FrameMaker; Smartsheet experience is a plus.
Strong understanding of structured documentation, document lifecycle management, and version control.
Experience working in a highly regulated environment with strict compliance requirements.
Excellent written and verbal communication skills with strong attention to detail.
Highly organized with the ability to manage multiple priorities in a fast‑paced environment.
Ability to work both independently and collaboratively to deliver high‑quality documentation.
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