Manufacturing Technical Writer

Job Description:

Confluent Medical Technologies is dedicated to working collaboratively with our customers, taking their projects from rapid prototype into high volume production. Our unparalleled technical expertise, proven experience and partnership with our clients has allowed us to perfect the process necessary to deliver world-class medical devices through innovative material science, engineering, and manufacturing. Our primary capabilities include: Nitinol components, balloon expandable stents and balloon catheters, delivery systems, biomedical textiles, access kits, and guidewires. We take pride in our position as the leader in the medical technology space and are driven by a passion to create products that our clients have envisioned for their customers.

We are looking for a Manufacturing Technical Writer to join our team in Austin, TX. As a uniquely qualified candidate, you will:

The Manufacturing Technical Writer is responsible for developing, revising, and maintaining clear, consistent, and technically accurate documentation that supports engineering, manufacturing, quality, and product lifecycle activities for medical device products and processes.

This role works closely with Process Development Engineering, Quality, Operations, and Supply Chain to translate engineering knowledge, process requirements, and quality system inputs into controlled documentation. The Technical Writer will draft a substantial portion of a broad range of documents—including work instructions, inspection procedures, purchasing specifications, protocols, reports, ERP part-creation documentation, and risk documentation—so that engineers can efficiently complete the final technical details before approval.

A key focus of the role is creating work instructions that can be effectively transferred and implemented by production personnel at Confluent manufacturing locations, including Costa Rica. The Technical Writer will also help establish consistent standards, templates, terminology, and practices for manufacturing documentation across the organization.

Key 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 required to support product development, production, and quality activities

• Support part creation and related documentation in the ERP system by gathering required information, preparing draft records or supporting documentation, and coordinating review with Engineering, Quality, Supply Chain, and Operations.

• 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, reduce ambiguity, and support manufacturing personnel with varying levels of technical experience and English proficiency.

• 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.

Required Qualifications

• 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
  

Preferred Qualifications

• 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.

Core Competencies

• Ability to translate engineering complexity into manufacturing simplicity
• Strong attention to technical accuracy, completeness, and documentation traceability
• Operator-centered communication
• Manufacturing and process orientation
• Cross-functional collaboration
• Ability to drive document drafts through review, approval, and release workflows
• Quality and regulatory awareness
• Visual communication
• Continuous-improvement mindset

We regret that we are unable to sponsor employment visas or consider individuals on time-limited visa status for this position.

Confluent Medical Technologies is an equal opportunity employer.

Only qualified candidates will be contacted.