Analog Devices, Inc

Software Medical Writer

Analog Devices, Inc$110K — $151K *
Healthcare
5 - 7 years of experience
Job Overview by Ladders

Qualifications

  • 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 IEC 62304, ISO 13485, ISO 14971, and FDA design controls
  • Experience working within Quality Management Systems (QMS/eQMS)
  • Demonstrated ability to translate complex technical details into clear documentation

Responsibilities

  • Lead the authoring and maintenance of software lifecycle documentation
  • Own and manage software requirements and verification documentation
  • Translate software intended use and risk controls into regulator-ready documentation
  • Support design control activities including verification and validation
  • Collaborate with Software Engineering and QA teams for documentation accuracy
  • Maintain software requirements and traceability using management tools
  • Drive documentation consistency and best practices across projects

Benefits

  • Medical, vision, and dental coverage
  • 401k plan
  • Paid vacation
  • Holidays and sick time
  • Discretionary performance-based bonus
Full Job Description
Senior Software Medical Writer - Medical Devices

We are seeking a Senior Software Medical 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 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.

About Analog Devices, Inc

Analog Devices (NYSE: ADI) defines innovation and excellence in signal processing. ADI's analog, mixed-signal, and digital signal processing (DSP) integrated circuits (IC) play a fundamental role in converting, conditioning, and processing real-world phenomena such as light, sound, temperature, motion, and pressure into electrical signals to be used in a wide array of electronic equipment. But that doesn't begin to capture the essence of what Analog Devices does for their customers, and ultimately for the end user.

Analog Devices, Inc Careers

Joining Analog Devices, Inc (ADI) offers an unparalleled opportunity to be part of a team that prides itself on innovation, leadership, and a diverse and inclusive culture. As a global leader in the semiconductor industry, ADI is the perfect place to advance your career, whether you're a seasoned professional or just starting out. Work You’ll Do At Analog Devices, Inc, you will collaborate with some of the brightest minds in the industry, working on groundbreaking projects that shape the future of technology. Our commitment to innovation is unwavering, and we empower our team to explore new ideas and solutions. Be Part of a Great Team ADI is not just about individual achievements but about collective success. Our team culture is built on collaboration, where each member’s skills and insights are valued. We believe in nurturing our employees' growth through comprehensive professional and diversity training programs that foster an inclusive environment. Innovate and Lead Step into a role at ADI and you’ll find yourself at the intersection of technology and innovation. Our leadership in designing and manufacturing semiconductor products allows us to push boundaries and think outside the box. Your work here leads to the development of solutions that not only meet but exceed our clients' expectations. Career Growth and Opportunities Your career at Analog Devices, Inc is filled with endless possibilities. We offer a variety of job opportunities across multiple functions, ensuring that your career trajectory is in your hands. From engineering to marketing, and from sales to research and development, every position contributes to our global success. Internship Programs Start your career journey with an internship at ADI, where you can apply your academic knowledge in a real-world setting. Our internships provide a robust platform for learning and development, making you job-ready and equipped with practical skills that stand out in your resume. Benefits and Culture Choosing a career at Analog Devices, Inc means more than just employment. It signifies becoming part of a company that values your well-being and professional development. Our benefits package is designed to support not only your individual needs but also those of your family, encompassing health, finance, and work-life balance. Join Our Team Explore the job opportunities and open positions on our Careers page. We are continuously hiring new talents who are passionate, curious, and eager to make a difference. Sharpen your skills through our training programs and prepare for your interview with confidence. Networking and Professional Development At ADI, networking and professional development are part of our DNA. Engage with leaders and peers through various events and platforms, enhancing your career prospects and gaining insights that are integral to professional growth. Stay Connected Keep up to date with the latest at Analog Devices, Inc by following our Careers Blog. Gain insider perspectives and industry-leading insights that can help you navigate your career path at ADI. Job Alert Emails Personalize your subscription to receive job alerts and the latest news tailored to your preferences. Discover the exciting and rewarding career opportunities waiting for you at Analog Devices, Inc. Join Analog Devices, Inc today and be part of a company that thrives on innovation, values diversity, and is dedicated to your professional growth.
Learn more about Analog Devices, Inc
Size
24,700 employees
Market Cap
$82.5 billion
Industry
Net Income
$1.4 billion
Founded
1965
5 Year Trend
+18%
Revenue
$5.8 billion
NASDAQ

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