California Staffing
Sr. Technical Writer (Medical Device, HW/SW, MadCap Flare)
California Staffing, Vista, California, United States, 92081
Senior Technical Writer
Are you ready to accelerate your potential and make a real difference within life sciences, diagnostics and biotechnology? At Leica Biosystems, one of Danaher's operating companies, our work saves livesand we're all united by a shared commitment to innovate for tangible impact. You'll thrive in a culture of belonging where you and your unique viewpoint matter. And by harnessing Danaher's system of continuous improvement, you help turn ideas into impact
innovating at the speed of life. At Leica Biosystems, we're not just shaping the future of cancer diagnostics
we're transforming lives. Our mission of "Advancing Cancer Diagnostics, Improving Lives" is the driving force behind everything we do. As a global leader with the most comprehensive portfolio spanning from biopsy to diagnosis, we empower clinicians with innovative, reliable solutions so they can give patients timely, accurate answers when they need them most. When you join Leica Biosystems, you're not just taking a job; you're becoming part of a passionate team that knows every moment matters when it comes to cancer. You'll help develop diagnostic solutions that turn anxiety into answers, and aid the acceleration of next-generation, life-changing therapies. Surrounded by a diverse and collaborative global community, you'll be inspired each day to stretch, grow, and make an impact. The Senior Technical Writer for Leica Biosystems creates accurate, compliant technical documentation for our Digital Pathology portfolio. Focused on internal and external customer needs, this role develops and maintains user guides, service manuals, and technical instructions that enable the safe, efficient installation, operation, and support of our products. You will collaborate closely with R&D, Quality, Regulatory, and Service & Support stakeholders to translate complex technical data into clear, usable content throughout the product lifecycle. Additionally, this role ensures all materials remain current with strict regulatory and business requirements. This position reports to the Manager, Technical Writing & Training, and is an onsite role 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 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 MadCap 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 (SMEs) 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 provide peer review to other writers to ensure consistency and quality across the team. The essential requirements of the job include: 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 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 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
It would be a plus if you also possess previous experience in: Working with medical devices or other regulated businesses Managing translation outsourcing projects Join our winning team today. Together, we'll accelerate the real-life impact of tomorrow's science and technology. We partner with customers across the globe to help them solve their most complex challenges, architecting solutions that bring the power of science to life.
Are you ready to accelerate your potential and make a real difference within life sciences, diagnostics and biotechnology? At Leica Biosystems, one of Danaher's operating companies, our work saves livesand we're all united by a shared commitment to innovate for tangible impact. You'll thrive in a culture of belonging where you and your unique viewpoint matter. And by harnessing Danaher's system of continuous improvement, you help turn ideas into impact
innovating at the speed of life. At Leica Biosystems, we're not just shaping the future of cancer diagnostics
we're transforming lives. Our mission of "Advancing Cancer Diagnostics, Improving Lives" is the driving force behind everything we do. As a global leader with the most comprehensive portfolio spanning from biopsy to diagnosis, we empower clinicians with innovative, reliable solutions so they can give patients timely, accurate answers when they need them most. When you join Leica Biosystems, you're not just taking a job; you're becoming part of a passionate team that knows every moment matters when it comes to cancer. You'll help develop diagnostic solutions that turn anxiety into answers, and aid the acceleration of next-generation, life-changing therapies. Surrounded by a diverse and collaborative global community, you'll be inspired each day to stretch, grow, and make an impact. The Senior Technical Writer for Leica Biosystems creates accurate, compliant technical documentation for our Digital Pathology portfolio. Focused on internal and external customer needs, this role develops and maintains user guides, service manuals, and technical instructions that enable the safe, efficient installation, operation, and support of our products. You will collaborate closely with R&D, Quality, Regulatory, and Service & Support stakeholders to translate complex technical data into clear, usable content throughout the product lifecycle. Additionally, this role ensures all materials remain current with strict regulatory and business requirements. This position reports to the Manager, Technical Writing & Training, and is an onsite role 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 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 MadCap 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 (SMEs) 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 provide peer review to other writers to ensure consistency and quality across the team. The essential requirements of the job include: 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 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 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
It would be a plus if you also possess previous experience in: Working with medical devices or other regulated businesses Managing translation outsourcing projects Join our winning team today. Together, we'll accelerate the real-life impact of tomorrow's science and technology. We partner with customers across the globe to help them solve their most complex challenges, architecting solutions that bring the power of science to life.