Sr. Technical Writer; Medical Device, HW​/SW, MadCap Flare

Sr. Technical Writer (Medical Device, HW/SW, Mad Cap Flare)

Join to apply for the Sr. Technical Writer (Medical Device, HW/SW, Mad Cap Flare) role at Leica Biosystems.

We are one of Danaher’s 15+ operating companies dedicated to innovating for tangible impact in life sciences, diagnostics, and biotechnology.

In this role, you will create accurate, compliant technical documentation for our Digital Pathology portfolio, supporting user guides, service manuals, and technical instructions that enable safe, efficient installation, operation, and support of our products.

• Own the technical writing swim lane for Digital Pathology programs for NPDs and CRs, acting as the primary writing resource within cross‑functional R&D and Service project teams.
• Develop and manage structured single source content using Mad Cap Flare, covering the full lifecycle from authoring and technical review to localization and release, ensuring high‑quality deliverables support the product roadmap.
• Ensure regulatory compliance by creating and maintaining all labeling, including user guides, service guides, and instructions that strictly adhere to FDA, EU MDR/IVDR, and ISO 13485 requirements, ensuring all materials are audit‑ready.
• Collaborate with subject matter experts in R&D, Quality, Service and more to translate complex technical specifications into clear, actionable content for both customer‑facing and internal service audiences.
• Drive process efficiency by identifying improvements in documentation workflows and styles within the CMS and providing peer review to other writers to ensure consistency and quality across the team.

• Bachelor’s degree in a scientific, technical, or engineering discipline (e.g., Biology, Biomedical Engineering, Computer Science).
• Prefer minimum of 5 years of experience as a Technical Writer creating documentation for medical devices, diagnostics, or life‑science instruments.
• Strong working knowledge of medical device regulations and quality standards, including FDA (21 CFR Part 820), EU IVDR/MDR, and ISO 13485.
• Demonstrated expertise with a Content Management System (CMS) or authoring tool, with advanced proficiency in Mad Cap Flare.
• Excellent verbal and written communication skills with a proven ability to analyze complex topics and translate them into clear, concise, and accurate documentation for diverse audiences.

Ability to travel