Analog Devices
Semiconductor
SeniorTechnicalWriter(Medical/Software)
Neural analysis suggests this role is
optimal for Senior candidates.
“Senior Technical Writer (Medical/Software) at Analog Devices. Skills: Software lifecycle documentation, Medical device software, Regulatory compliance, Technical writing. Lead authoring and maintenance of software lifecycle documentation. Own and maintain software requirements”
Industry & Context.
10% travel
What They're Looking For.
Must Have
Bachelor's degree in scientific, engineering, or technical discipline, 5+ years experience in medical, regulatory, or technical writing, Proven experience documenting medical device software or SaMD, Understanding of SDLC, verification, and validation concepts, Hands-on experience with IEC 62304, ISO 13485, ISO 14971, FDA design controls, Experience working within QMS/eQMS and formal document control, Demonstrated ability to translate complex software designs, Excellent written communication skills, Cross-functional collaboration skills, Stakeholder communication skills, Prior participation in FDA audits or notified body audits
Nice to Have
Advanced degree preferred, Experience implementing ISO 13485 and 21 CFR Part 820, Background in software development, Solid grasp of core software engineering principles, Experience with Git-based version control, Experience documenting connected devices, Experience documenting mobile applications, Experience documenting cloud-connected medical software, Familiarity with Agile or hybrid development environments, Experience authoring risk management files, Experience authoring traceability artifacts, Experience validating user-facing labeling
What You'll Do.
Lead authoring and maintenance of software lifecycle documentation
Own and maintain software requirements
Own and maintain architecture descriptions
Own and maintain design descriptions
Own and maintain verification documentation
Own and maintain validation documentation
Own and maintain traceability matrices
Translate software intended use
Translate system behavior
Translate risk controls
Support design control activities
Support design inputs
Support design outputs
Support design verification
Support design validation
Support design change management
Collaborate with Software Engineering
Collaborate with QA teams
Maintain IEC 62304-compliant traceability
Support software project execution
Support internal audits
Support external audits
Support regulatory submissions
Drive documentation consistency
Drive documentation quality
Drive documentation best practices
How You'll Work.
Team & Collaboration
Software Engineering teams; Quality Assurance teams; Product teams; Cross-functional teams
Communication Scope
Written communication; Stakeholder communication
Full Job Description
**About Analog Devices** Analog Devices, Inc. (NASDAQ: _[ADI](http://finance.yahoo.com/q?s=ADI)_ ) is a global semiconductor leader that bridges the physical and digital worlds to enable breakthroughs at the Intelligent Edge. ADI combines analog, digital, and software technologies into solutions that help drive advancements in digitized factories, mobility, and digital healthcare, combat climate change, and reliably connect humans and the world. With revenue of more than $9 billion in FY24 and approximately 24,000 people globally, ADI ensures today's innovators stay Ahead of What's Possible™. Learn more at _[www.analog.com](https://www.analog.com/)_ and on _[LinkedIn](https://www.linkedin.com/company/analog-devices/posts/?feedView=all)_ and _[Twitter (X)](https://x.com/adi_news)_. **Senior Technical Writer (Medical/ Software)** We are seeking a Senior Technical Writer to lead the creation and maintenance of software lifecycle documentation for medical device software developed in regulated healthcare environments. This role plays a critical part in ensuring compliance with FDA and international standards by translating complex software design, behavior, and risk controls into clear, accurate, and audit‑ready documentation. Working closely with Software Engineering, Quality, Regulatory Affairs, and Product teams across the full software development lifecycle. **Description** * Lead the authoring and maintenance of software lifecycle documentation in compliance with IEC 62304, ISO 13485, ISO 14971, and FDA 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 closely with Software Engineering and QA teams to ensure document
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