Technical Writer

About the position

The Technical Writer will play a crucial role in supporting the development and release of cutting-edge medical device software. This position involves collaborating closely with development, product, and regulatory teams to produce clear, accurate, and compliant documentation. From defining features for the development team to creating engaging release notes and regulatory materials, the Technical Writer ensures that all written content supports both internal and external audiences effectively and adheres to medical device industry standards.

Responsibilities

• Collaborate with product managers, clinicians, business analysts, and developers to refine feature definitions and ensure alignment with user and business needs.
• Translate technical and clinical specifications into user-friendly descriptions to guide the development team.
• Document workflows, diagrams, and use cases to clarify complex processes for stakeholders.
• Produce clear, concise release notes to communicate new features, enhancements, and bug fixes to end-users and stakeholders.
• Create engaging and informative release videos that demonstrate new features and their functionality.
• Ensure consistency and accuracy in all release-related communications, aligning with brand and regulatory guidelines.
• Develop and maintain labeling, user manuals, and clinical guides in compliance with medical device industry standards (e.g., IEC 62304, FDA, MDR).
• Work closely with the regulatory team to ensure all documentation meets submission requirements for global markets.
• Maintain version control and ensure traceability of documentation to software requirements.
• Act as a liaison between technical teams and non-technical stakeholders to ensure mutual understanding of documentation requirements.
• Facilitate feedback sessions with users, clinicians, and other stakeholders to improve documentation usability.
• Support the development and maintenance of a style guide to standardize content across the organization.
• Use user feedback and usability testing to refine and improve documentation quality and accessibility.
• Stay up to date on medical device documentation best practices and industry standards.
• Explore new tools and techniques to streamline the documentation process and enhance its impact.

Requirements

• Bachelor's Degree in related field.
• 3 years’ experience in technical writing is required.
• Biotechnology industry experience is preferred.

Nice-to-haves

• Exceptional writing, editing, and organizational skills.
• Proficiency with documentation tools such as Adobe FrameMaker, MadCap Flare, or Microsoft Word.
• Familiarity with Agile development environments and tools like Azure DevOps.
• Basic understanding of software development processes and the ability to read and interpret technical documents.
• Experience producing multimedia content, including instructional videos and graphics.
• Experience creating and maintaining traceable documentation in compliance with industry standards.
• Familiarity with UX principles and the ability to collaborate with design teams to create user-friendly content.
• Strong interpersonal skills to work effectively across multidisciplinary teams.

Benefits

• Competitive salaries.
• Performance-based incentives.
• A wide variety of benefits programs to address the diverse individual needs of employees and their families.