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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in technical writing for medical device documentation, ensuring compliance with FDA, IVDR, and EU regulations while managing multiple projects and collaborating with cross-functional teams.
Highest-signal resume keywords
Technical WritingMedical Device Industry ExperienceFDA ComplianceDocument Control ManagementAdvanced Writing/Editing Skills
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Technical WritingDocument DevelopmentChange Control ManagementMedical TerminologyTopic-Based AuthoringContent ReuseConditional TextVersion ControlTranslation ManagementQuality Assurance
Soft Skills
Excellent Communication SkillsSelf-DirectedHighly OrganizedCollaborative NatureAbility to Manage Multiple Priorities
Tools & Technologies
Microsoft 365SharePointAdobe FrameMakerAdobe Acrobat ProVisioSnagIt EditorConfluenceJiraLSQMElectronic Documentation Control System
Industry Keywords
Regulatory ComplianceQSR RequirementsEnd-User DocumentationSoftware InstructionsHardware InstructionsTranslation ReviewsDocument FormattingCross-Functional CollaborationGlobal StakeholdersChange History
About the role
Key responsibilities & impact- Provide technical writing support for instrument and software operator manuals, service manuals, and technical bulletins
- Revise and edit legacy product documentation
- Manage translation projects with the translation vendor and perform translation reviews for consistency with formatting and layout
- Manage multiple projects, scope changes, and shifting priorities while maintaining requirements and deadlines
- Process documents through the electronic documentation control system (LSQM)
- Manage document development and assist in production release, including draft reviews
- Maintain version control, change history, traceability, revision control, change lists, and reviews for deliverables
- Ensure documentation is accurate, complete, compliant with specifications, and adheres to quality and style standards
- Ensure labeling compliance with applicable regulatory/QSR requirements
- Create and edit documentation in compliance with FDA, IVDR, EUDR, and EU Medical Device Regulation requirements
- Collaborate with departmental and cross-functional peers to resolve questions and issues during document development
- Review the document development process to ensure quality in labeling output
- Track documentation through the entire development process and maintain timelines
Requirements
What you’ll need- Bachelor's degree, preferably in English or Technical Communication, similar related fields
- Minimum five years of experience writing end-user software or hardware instructions
- Experience in the medical device industry preferred
- Experience working in a federally regulated environment (FDA/UMDR)
- Advanced writing/editing skills
- Self-directed and highly organized
- Ability to manage multiple priorities
- Excellent communication skills
- Cross-functional, collaborative nature
- Proven ability to work with global stakeholders
- Experience maintaining accurate change lists, content change control, and file version control throughout documentation development
- Familiarity with topic-based authoring, content reuse, conditional text, and variables
- Medical terminology experience
- Proficiency with Microsoft 365 applications, SharePoint, Adobe FrameMaker, and Adobe Acrobat Pro
- Experience using Visio and SnagIt Editor or similar applications to create diagrams, illustrations, flow charts, and screenshots
- Experience using Confluence, Jira, or similar collaboration and tracking tools
- Hands-on experience with instrumentation and software
Benefits
Comp & perks- Up to 8% of the company bonus pool
- Medical insurance
- Dental insurance
- Vision insurance
- Life insurance
- PTO
- Paid holidays
- Up to 5% 401(K) match
- Tuition reimbursement
- Opportunities for professional growth and career progression
- Family-like culture