Analog Devices
Semiconductor
SeniorTechnicalWriter(Medical/Software)
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“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. Ensure compliance with IEC 62304, ISO 13485, ISO 14971, FDA regulations”
What You'll Achieve.
Ensure compliance with FDA and international standards; Clear, accurate, and audit‑ready documentation
Industry & Context.
10% travel
What They're Looking For.
Must Have
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 or Software as a Medical Device (SaMD), understanding of software development lifecycle (SDLC), verification, and validation concepts, Hands‑on experience with standards and regulations such as IEC 62304, ISO 13485, ISO 14971, and FDA design controls, Experience working within Quality Management Systems (QMS/eQMS) and formal document control processes, Demonstrated ability to translate complex software designs and technical details into clear, structured, and audit‑ready documentation, Excellent written communication skills with attention to detail and consistency, cross‑functional collaboration and stakeholder communication skills, Prior participation in FDA audits, notified body audits, or inspection readiness activities
Nice to Have
Advanced degree, Experience implementing and working within ISO 13485 and 21 CFR Part 820 quality system requirements, Background in software development with a solid grasp of core software engineering principles, Git-based version control, development practices, 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, including in‑app labeling, on‑device labeling, and instructions for use (IFU)
What You'll Do.
Lead authoring and maintenance of software lifecycle documentation
Ensure compliance with IEC 62304
Own and maintain software requirements
Own and maintain architecture and design descriptions
Own and maintain verification and validation documentation
Own and maintain traceability matrices
Translate software intended use
Translate system behavior
Translate risk controls into documentation
Support design control activities
Support software project execution
Drive documentation consistency
Drive documentation quality
Drive documentation best practices
How You'll Work.
Team & Collaboration
Working closely with Software Engineering, Quality, Regulatory Affairs, and Product teams; Collaborate closely with Software Engineering and QA teams; Collaborating with development and QA teams
Communication Scope
Excellent written communication skills; Attention to detail; Consistency; Cross-functional collaboration; Stakeholder communication skills
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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