Senior Technical Writer (Medical/Software)

About Analog Devices

Analog Devices, Inc. (NASDAQ: ADI) is a global semiconductor leader that bridges the physical and digital worlds to enable breakthroughs at the Intelligent Edge. ADI combines analog, digital, AI, and software technologies into solutions that combat climate change, reliably connect humans and the world, and help drive advancements in automation and robotics, mobility, healthcare, energy and data centers. With revenue of more than $11 billion in FY25, ADI ensures today's innovators stay Ahead of What's Possible. Learn more at www.analog.com and on LinkedIn and X.

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

Collaborate closely with Software Engineering and QA teams to ensure documentation accurately reflects implemented functionality and test evidence

Maintain IEC 62304–compliant end‑to‑end software requirements and verification traceability using requirements management tools such as Jama, Polarion ALM, DOORS, or equivalent ALM/RM systems.

Support software project execution by collaborating with development and QA teams through JIRA 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

Requirements

Bachelor’s degree in a scientific, engineering, or technical discipline (advanced degree preferred)

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)

Strong 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 strong attention to detail and consistency

Strong cross‑functional collaboration and stakeholder communication skills

Prior participation in FDA audits, notified body audits, or inspection readiness activities

Preferred Qualifications

Experience implementing and working within ISO 13485 and 21 CFR Part 820 quality system requirements is strongly preferred

Preferred background in software development with a solid grasp of core software engineering principles, Git‑based version control, and 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)

For positions requiring access to technical data, Analog Devices, Inc. may have to obtain export licensing approval from the U.S. Department of Commerce - Bureau of Industry and Security and/or the U.S. Department of State - Directorate of Defense Trade Controls. As such, applicants for this position – except US Citizens, US Permanent Residents, and protected individuals as defined by 8 U.S.C. 1324b(a)(3) – may have to go through an export licensing review process.

Job Req Type: Experienced

Required Travel: Yes, 10% of the time

Shift Type: 1st Shift/Days

The expected wage range for a new hire into this position is $110,385 to $151,808.

Actual wage offered may vary depending on work location, experience, education, training, external market data, internal pay equity, or other bona fide factors.

This position qualifies for a discretionary performance-based bonus which is based on personal and company factors.

This position includes medical, vision and dental coverage, 401k, paid vacation, holidays, and sick time, and other benefits.