Manufacturing Technical Writer at Confluent Medical Technologies | Austin, TX, US | Rezi

Manufacturing Technical Writer at Confluent Medical Technologies

Manufacturing Technical Writer

Confluent Medical Technologies · Austin, TX, US

4 days ago

Manufacturing Technical Writer

Confluent Medical Technologies · Austin, TX, US

5 days ago
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About the Role

Confluent Medical Technologies is seeking a Manufacturing Technical Writer in Austin, TX, to develop and maintain clear, accurate documentation supporting engineering, manufacturing, quality, and product lifecycle activities for medical devices. This role is crucial for translating engineering knowledge into controlled documents and ensuring effective implementation by production personnel.

Responsibilities

  • Shadow engineers and technicians during development and pilot builds to capture manufacturing processes and create clear, accurate work instructions.
  • Develop documentation from direct observation, engineering inputs, drawings, specifications, build notes, design outputs, test data, supplier information, ERP requirements, risk-management inputs, and draft procedures.
  • Review, simplify, and standardize engineer-generated work instructions to improve clarity, consistency, and usability for production operators.
  • Create, revise, and standardize inspection procedures, purchasing specifications, protocols, technical reports, manufacturing work instructions, and other controlled documentation.
  • Support part creation and related documentation in the ERP system by gathering required information, preparing draft records or supporting documentation, and coordinating review.
  • Transform complex or text-heavy procedures into clear, visual, step-by-step instructions using photographs, diagrams, tables, pictograms, and other operator-friendly formats.
  • Apply plain-language, controlled-language, and user-centered principles to improve comprehension and reduce ambiguity.
  • Develop documentation that supports effective manufacturing and process transfer from U.S. development sites to production operations, including Confluent's Costa Rica site.
  • Collaborate with Engineering, Quality, Operations, and Training to verify technical accuracy and ensure documentation reflects approved manufacturing processes.
  • Ensure documentation complies with applicable Quality Management System, document control, regulatory, ERP, purchasing, inspection, validation, and risk-management requirements.
  • Identify gaps, inconsistencies, and ambiguity in manufacturing documentation and work with subject-matter experts to resolve them.
  • Route completed documents through Confluent's Quality Management System and document-control workflows, coordinating approvals, resolving review comments, and ensuring final records are released appropriately.
  • Help establish and continuously improve documentation templates, terminology, visual standards, style guidelines, and workflows.
  • Provide guidance to engineers and other subject-matter experts on effective manufacturing documentation practices.
  • Perform other related duties as assigned.

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.
  • Demonstrated experience creating or maintaining controlled technical documentation such as manufacturing work instructions, SOPs, inspection procedures, specifications, protocols, reports, risk documentation, or similar records.
  • Ability to understand technical processes and translate complex engineering information into clear, concise, operator-ready instructions.
  • Experience working directly with engineers, technicians, operators, and other technical subject-matter experts.
  • Familiarity with Quality Management Systems, document control, approval routing, revision-controlled documentation, and cross-functional technical review processes.
  • Strong written, verbal, visual communication, and cross-functional collaboration skills.
  • Ability to independently manage multiple documentation projects and priorities.
  • Ability to gather incomplete or preliminary technical inputs, organize them into structured drafts, and work with engineers to finalize technical details.
  • Experience in medical device manufacturing and FDA- and/or ISO-regulated environments.
  • Experience supporting new product introduction, design transfer, manufacturing transfer, or process validation.
  • Experience with ERP part setup, item master data, bills of material, purchasing specifications, supplier documentation, inspection planning, or related product lifecycle documentation.
  • Experience developing visual work instructions for manufacturing personnel or audiences with varying English proficiency.
  • Spanish-language proficiency and/or experience supporting manufacturing operations in Costa Rica or Latin America.
  • Willingness to travel up to 25% on occasion, including Costa Rica, to support project work.
  • Proficiency with Microsoft Word, graphics/image-editing tools, and electronic document management systems.

Skills

  • Technical Writing
  • Manufacturing Documentation
  • Medical Device Documentation
  • Quality Management Systems
  • Document Control
  • ERP Systems
  • Risk Management
  • Process Transfer
  • Visual Communication
  • Plain Language
  • Controlled Language
  • User-Centered Design
  • Cross-functional Collaboration
  • Microsoft Word
  • Graphics/Image Editing
  • Electronic Document Management Systems

Location

  • Austin, TX

Work Type

  • Full-time

Experience Level

  • 3-5+ years

Education Level

  • Bachelor's degree in Technical Writing, Communications, Engineering, Manufacturing, or a related field, or equivalent relevant experience.

About the Company

  • Confluent Medical Technologies is dedicated to working collaboratively with customers, taking projects from rapid prototype into high volume production.
  • The company possesses unparalleled technical expertise, proven experience, and strong client partnerships, enabling the delivery of world-class medical devices through innovative material science, engineering, and manufacturing.
  • Primary capabilities include Nitinol components, balloon expandable stents and balloon catheters, delivery systems, biomedical textiles, access kits, and guidewires.
  • Confluent Medical Technologies holds a leadership position in the medical technology space, driven by a passion to create envisioned products.

Equal Opportunity

  • Confluent Medical Technologies is an equal opportunity employer.