Senior Technical Writer (Medical/Software)
Analog Devices•Wilmington, MA
•$110,385 - $151,808•Onsite
About The Position
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.
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
Nice To Haves
- 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)
Responsibilities
- 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
Benefits
- medical, vision and dental coverage
- 401k
- paid vacation, holidays, and sick time
- discretionary performance-based bonus
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What This Job Offers
Job Type
Full-time
Career Level
Senior
