About This Role
We are seeking a Technical Writer to create and maintain software documentation for medical device software in regulated healthcare environments. This role is critical in ensuring compliance with industry standards by translating complex software design into clear, accurate, audit-ready documentation. You’ll work closely with Software Engineering, Quality, Regulatory, and Product teams throughout the software development lifecycle.
What You’ll Do
• Author and maintain software lifecycle documentation in compliance with relevant industry standards and regulations
• Own and maintain software requirements, architecture and design descriptions, verification and validation documentation, and traceability matrices
• Translate software intended use, system behavior, and risk controls into clear, regulator-ready documentation
• Support design control activities including design inputs, outputs, verification, validation, and change management
• Collaborate with Software Engineering and quality assurance teams to ensure documentation accurately reflects implemented functionality and test evidence
• Maintain end-to-end software requirements and verification traceability using requirements management tools
• Support software project execution by collaborating with development and quality teams using project tracking tools for test execution, verification tracking, and defect management
• Support internal and external audits, inspections, and regulatory submissions with audit-ready documentation
• Drive documentation consistency, quality, and best practices across projects
Skills/background needed: Bachelor’s degree in a scientific, engineering, or technical discipline; 5+ years of experience in medical, regulatory, or technical writing within regulated environments; proven experience documenting medical device software; strong understanding of software development lifecycle, verification, and validation concepts; hands-on experience with relevant industry standards and regulations; experience working within Quality Management Systems and formal document control processes; demonstrated ability to translate complex software designs into clear, structured documentation; excellent written communication skills with strong attention to detail; strong cross-functional collaboration skills; prior participation in audits or inspection readiness activities.
Preferred: Background in software development with understanding of software engineering principles and version control; experience documenting connected devices, mobile applications, and cloud-connected medical software; familiarity with Agile or hybrid development environments; experience authoring or maintaining risk management files and traceability artifacts; experience validating user-facing labeling and instructions for use.
Rate: Competitive entry-level pay, details shared upon application.
Contract length: Full-time, permanent
Location: Fully remote
This position includes medical, vision and dental coverage, 401k, paid vacation, holidays, and sick time.
Ready to get started? Submit your application below.