Leica Biosystems
Sr. Technical Writer (Medical Device, HW/SW, MadCap Flare)
Leica Biosystems, San Diego, California, United States, 92189
Sr. Technical Writer (Medical Device, HW/SW, MadCap Flare)
Apply for the
Sr. Technical Writer (Medical Device, HW/SW, MadCap Flare)
role at
Leica Biosystems .
Bring more to life.
Accelerate your potential and make a real difference in life sciences, diagnostics, and biotechnology. Leica Biosystems, part of Danaher’s portfolio, saves lives through innovation. Join a culture that values belonging and continuous improvement, shaping the future of cancer diagnostics and supporting clinicians worldwide.
The
Senior Technical Writer
creates accurate, compliant documentation for our Digital Pathology portfolio. You develop and maintain user guides, service manuals, and technical instructions, collaborating with R&D, Quality, Regulatory, and Service & Support stakeholders to translate complex technical data into clear, usable content. Your work ensures all materials remain current with regulatory and business requirements. This onsite role is based in the Digital Pathology Business Unit in Vista, CA.
In This Role, You Will Have The Opportunity To
Own the technical writing swim lane for Digital Pathology programs, serving as the primary writing resource in cross‑functional R&D and Service project teams.
Develop and manage structured single‑source content using MadCap Flare throughout the product lifecycle.
Ensure regulatory compliance by creating and maintaining labeling, including user guides, service guides, and instructions that strictly adhere to FDA, EU MDR/IVDR, and ISO 13485 requirements.
Collaborate with SMEs in R&D, Quality, Service, and more to translate complex specifications into clear, actionable content for customer‑facing and internal audiences.
Drive process efficiency by identifying improvements in documentation workflows and styles within the CMS and providing peer review to other writers.
Essential Requirements
Bachelor’s degree in a scientific, technical, or engineering discipline (e.g., Biology, Biomedical Engineering, or Computer Science).
Prefer minimum of 5 years of experience as a Technical Writer 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 CMS or authoring tool, with advanced proficiency in MadCap 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.
Travel Requirements Ability to travel
Preferred Experience
Working with medical devices or other regulated businesses.
Managing translation outsourcing projects.
Leica Biosystems offers a broad array of competitive benefits, including paid time off, medical/dental/vision insurance, and a 401(k) plan.
Annual salary range for this role: $100,000 – $115,000. This is the range believed to be possible compensation for this role at the time of posting. The range may be modified in the future. The position may also be eligible for bonus and incentive pay.
Danaher Corporation and all Danaher Companies are committed to equal opportunity regardless of race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law.
We comply with federal and state disability laws and make reasonable accommodations for applicants and employees with disabilities. If a reasonable accommodation is needed, please contact 1-202-419-7762 or applyassistance@danaher.com.
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Sr. Technical Writer (Medical Device, HW/SW, MadCap Flare)
role at
Leica Biosystems .
Bring more to life.
Accelerate your potential and make a real difference in life sciences, diagnostics, and biotechnology. Leica Biosystems, part of Danaher’s portfolio, saves lives through innovation. Join a culture that values belonging and continuous improvement, shaping the future of cancer diagnostics and supporting clinicians worldwide.
The
Senior Technical Writer
creates accurate, compliant documentation for our Digital Pathology portfolio. You develop and maintain user guides, service manuals, and technical instructions, collaborating with R&D, Quality, Regulatory, and Service & Support stakeholders to translate complex technical data into clear, usable content. Your work ensures all materials remain current with regulatory and business requirements. This onsite role is based in the Digital Pathology Business Unit in Vista, CA.
In This Role, You Will Have The Opportunity To
Own the technical writing swim lane for Digital Pathology programs, serving as the primary writing resource in cross‑functional R&D and Service project teams.
Develop and manage structured single‑source content using MadCap Flare throughout the product lifecycle.
Ensure regulatory compliance by creating and maintaining labeling, including user guides, service guides, and instructions that strictly adhere to FDA, EU MDR/IVDR, and ISO 13485 requirements.
Collaborate with SMEs in R&D, Quality, Service, and more to translate complex specifications into clear, actionable content for customer‑facing and internal audiences.
Drive process efficiency by identifying improvements in documentation workflows and styles within the CMS and providing peer review to other writers.
Essential Requirements
Bachelor’s degree in a scientific, technical, or engineering discipline (e.g., Biology, Biomedical Engineering, or Computer Science).
Prefer minimum of 5 years of experience as a Technical Writer 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 CMS or authoring tool, with advanced proficiency in MadCap 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.
Travel Requirements Ability to travel
Preferred Experience
Working with medical devices or other regulated businesses.
Managing translation outsourcing projects.
Leica Biosystems offers a broad array of competitive benefits, including paid time off, medical/dental/vision insurance, and a 401(k) plan.
Annual salary range for this role: $100,000 – $115,000. This is the range believed to be possible compensation for this role at the time of posting. The range may be modified in the future. The position may also be eligible for bonus and incentive pay.
Danaher Corporation and all Danaher Companies are committed to equal opportunity regardless of race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law.
We comply with federal and state disability laws and make reasonable accommodations for applicants and employees with disabilities. If a reasonable accommodation is needed, please contact 1-202-419-7762 or applyassistance@danaher.com.
#J-18808-Ljbffr