Sr. Technical Writer (Medical Device, HWSW, MadCap Flare)

Bring more 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 Danahers 15 operating companies our work saves livesand were all united by a shared commitment to innovate for tangible impact.

Youll thrive in a culture of belonging where you and your unique viewpoint matter. And by harnessing Danahers system of continuous improvement you help turn ideas into impact innovating at the speed of life.

At Leica Biosystems were not just shaping the future of cancer diagnostics were 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 youre not just taking a job; youre becoming part of a passionate team that knows every moment matters when it comes to cancer. Youll 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 youll be inspired each day to stretch grow and make an impact.

Learn about the Danaher Business System which makes everything possible.

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:

• Bachelors degree in a scientifictechnicalor engineering discipline ( Engineeringor Computer Science).
• Prefer minimum of5 years of experienceas a Technical Writer creating documentation formedical devices diagnostics or life science instruments.
• Strong working knowledge of medical device regulations and quality standardsincludingFDA (21 CFR Part 820) EU IVDR/MDR and ISO 13485.
• Demonstrated expertise with a Content Management System (CMS) or authoring toolwithadvanced proficiency in MadCap Flare.
• Excellent verbal and written communication skills with a proven ability to analyze complex topics and translate them into clearconciseand accurate documentation for diverse audiences.

Travel Requirements:

• Ability to travel <10% domestically or internationally

It would be a plus if you also possess previous experience in:

• Working with medical devices or other regulated businesses
• Managing translation outsourcing projects

Leica Biosystems a Danaher operating company offers a broad array of comprehensive competitive benefit programs that add value to our lives. Whether its a health care program or paid time off our programs contribute to life beyond the job. Check out our benefits at Danaher Benefits Info.

The annual salary range for this role is $100000 - $115000. This is the range that we in good faith believe is the range of possible compensation for this role at the time of this posting. This range may be modified in the future.

This job is also eligible for bonus/incentive pay.

We offer comprehensive package of benefits including paid time off medical/dental/vision insurance and 401(k) to eligible employees.

Note: No amount of pay is considered to be wages or compensation until such amount is earned vested and determinable. The amount and availability of any bonus commission benefits or any other form of compensation and benefits that are allocable to a particular employee remains in the Companys sole discretion unless and until paid and may be modified at the Companys sole discretion consistent with the law.

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Join our winning team today. Together well accelerate the real-life impact of tomorrows 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.

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