Medical Device Manufacturing Technical Writer

Confluent Medical Technologies; Austin (TX); Vor Ort; USD 70.000 - 110.000; Vollzeit

Zusammenfassung

Confluent Medical Technologies in Austin, TX seeks a Manufacturing Technical Writer to create, revise, and maintain clear, accurate documentation for medical device engineering, manufacturing, quality, and lifecycle activities.

You will translate engineering knowledge into operator-ready work instructions, SOPs, and protocols, collaborating with engineering, quality, and manufacturing teams to standardize templates and terminology across the organization, including Costa Rica.

Qualifikationen

• 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 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

Aufgaben

• 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.

Kenntnisse

Technical writing

Manufacturing

Medical devices

SOPs

Procedures

Ausbildung

Bachelor’s degree or equivalent

Tools

ERP

MS Word

Jobbeschreibung

Confluent Medical Technologies in Austin, TX seeks a Manufacturing Technical Writer to create, revise, and maintain clear, accurate documentation for medical device engineering, manufacturing, quality, and lifecycle activities.

You will translate engineering knowledge into operator-ready work instructions, SOPs, and protocols, collaborating with engineering, quality, and manufacturing teams to standardize templates and terminology across the organization, including Costa Rica.