Назад
Company hidden
1 час назад

Manufacturing Technical Writer (Medical Devices)

Формат работы
onsite
Тип работы
fulltime
Английский
b2
Страна
US
Вакансия из списка Hirify.GlobalВакансия из Hirify Global, списка международных tech-компаний
Для мэтча и отклика нужен Plus

Мэтч & Сопровод

Для мэтча с этой вакансией нужен Plus

Описание вакансии

Текст:
/
TL;DR
Manufacturing Technical Writer (Medical Devices): Developing and maintaining controlled documentation for medical device manufacturing, engineering, quality, and product lifecycle activities with an accent on operator-ready work instructions, inspection procedures, specifications, and process-transfer documentation. Focus on translating complex engineering inputs into clear visual instructions, standardizing documentation across U.S. and Costa Rica operations, and routing records through quality and document-control workflows.

Location: Austin, Texas, United States; occasional travel of up to 25%, including Costa Rica, may be required.

Company

hirify.global develops and manufactures medical device components and systems, including Nitinol components, stents, balloon catheters, delivery systems, biomedical textiles, access kits, and guidewires.

What you will do

  • Shadow engineers and technicians during development and pilot builds to document manufacturing processes and create work instructions.
  • Draft, revise, and standardize controlled documentation, including inspection procedures, purchasing specifications, protocols, technical reports, and risk documentation.
  • Convert complex procedures into clear, visual, step-by-step instructions using photographs, diagrams, tables, and pictograms.
  • Support ERP part creation and related product lifecycle documentation in collaboration with Engineering, Quality, Supply Chain, and Operations.
  • Develop documentation supporting manufacturing and process transfer from U.S. development sites to production operations, including Costa Rica.
  • Route documents through quality management and document-control workflows, coordinate approvals, resolve review comments, and improve templates and documentation standards.

Requirements

  • Bachelor’s degree in Technical Writing, Communications, Engineering, Manufacturing, or a related field, or equivalent relevant experience.
  • 3–5+ years of technical writing experience in manufacturing, medical devices, life sciences, or another regulated environment.
  • Experience creating or maintaining controlled technical documentation such as work instructions, SOPs, inspection procedures, specifications, protocols, reports, or risk documentation.
  • Ability to understand technical processes and translate engineering information into clear, concise, operator-ready instructions.
  • Experience collaborating with engineers, technicians, operators, and other technical subject-matter experts, while managing multiple documentation projects.
  • Familiarity with quality management systems, document control, approval routing, revision-controlled documentation, and cross-functional technical reviews.

Nice to have

  • Medical device manufacturing experience in FDA- or ISO-regulated environments.
  • Experience with new product introduction, design transfer, manufacturing transfer, or process validation.
  • Experience with ERP part setup, item master data, bills of material, supplier documentation, or inspection planning.
  • Spanish-language proficiency or experience supporting manufacturing operations in Costa Rica or Latin America.
  • Proficiency with Microsoft Word, graphics and image-editing tools, and electronic document management systems.

Culture & Benefits

  • Cross-functional work with Engineering, Quality, Operations, Supply Chain, and Training.
  • Focus on technical accuracy, traceability, operator-centered communication, and continuous improvement.
  • Employment visas are not sponsored, and individuals on time-limited visa status are not considered.

Будьте осторожны: если работодатель просит войти в их систему, используя iCloud/Google, прислать код/пароль, запустить код/ПО, не делайте этого - это мошенники. Обязательно жмите "Пожаловаться" или пишите в поддержку. Подробнее в гайде →