Technical Publications Engineer 3

Overview

Technical Publication engineer III is responsible for development, maintenance, and continuous improvement of product information and documentation solutions for existing and future products. This position serves as a senior technical writer for technical publications, document architecture, content management, localization, and regulatory documentation requirements. The role collaborates with cross-functional teams including Marketing, R&D, Quality, Regulatory Affairs, Clinical Education, Service, and Manufacturing to ensure documentation supports customer needs, product usability, regulatory compliance, and business objectives.

Technical Publication engineer III provides strategic guidance on content development processes, drives documentation standards and best practices, and manages complex documentation projects across multiple product portfolios.

Responsibilities

• Provide the planning, development, review, approval, and maintenance of product documentation, including Instructions for Use (IFUs), Operator Manuals, Service Manuals, Installation Guides, Security manuals, System Administration manuals, Data sheets, Release Notes, and Online help systems.
• Define documentation strategies, content architecture, and information design standards to improve usability and consistency across product lines.
• Establish and maintain technical writing standards, templates, style guides, and controlled documentation processes.
• Evaluate and implement best practices for structured authoring, content reuse, and documentation efficiency.
• Serve as the publication’s representative on new product development and sustaining engineering projects.
• Partner with Engineering, Product Management, Regulatory Affairs, Clinical Affairs, Quality Assurance, Human Factors Engineering, and Service teams to gather and validate technical information.
• Provide documentation impact assessments for product changes, design updates, and regulatory submissions.
• Participate in design reviews, risk management activities, verification and validation reviews, and product launch planning.
• Ensure documentation complies with applicable regulatory requirements, including FDA, EU MDR, ISO 13485, IEC 62366, and other global medical device regulations.
• Support regulatory submissions and audit activities by providing documentation expertise and evidence of compliance.
• Review labeling, safety information, warnings, cautions, and instructions to ensure consistency with regulatory requirements.
• Supporting the global localization activities and coordinate translation vendors to support worldwide product releases.
• Define localization strategies and workflows to improve quality, consistency, and delivery timelines.
• Manage content within document control systems, Quality Management Systems (QMS), Content Management Systems (CMS), and Translation Management Systems (TMS).
• Manage multiple complex documentation projects with minimal supervision.
• Develop project schedules, identify risks, and ensure timely delivery of documentation deliverables.
• Drive continuous improvement initiatives related to documentation tools, workflows, automation, and content development processes.
• Identify opportunities to improve documentation quality, usability, and operational efficiency.
• Conduct peer reviews and provide constructive feedback to ensure high-quality content.
• Promote best practices in technical communication and content development
• Uphold the company’s core values of Integrity, Innovation, Accountability, and Teamwork.
• Demonstrate behavior consistent with the company’s Code of Ethics and Conduct.
• It is the responsibility of every employee to report to their manager or a member of senior management any quality problems or defects in order for corrective action to be implemented and to avoid recurrence of the problem.
• Duties may be modified or assigned at any time to meet the needs of the business.

Qualifications

• Minimum 8+ years of technical writing experience, preferably within the medical device, healthcare, life sciences, or other regulated industries.
• Bachelor’s degree in engineering, Life Sciences, Biomedical Engineering, or related discipline required.
• Demonstrated experience leading complex technical documentation projects from concept through product release.
• Experience supporting regulatory compliance and quality system requirements in regulated environments.
• Expert proficiency with Adobe FrameMaker, InDesign, Photoshop, and Microsoft Office.
• Strong experience with Structured FrameMaker, XML, DITA, CMS, and TMS platforms.
• Experience with graphics creation, content reuse strategies, and structured authoring methodologies.
• Familiarity with software development life cycle (SDLC), Agile methodologies, and product development processes.
• Working knowledge of usability engineering, and human factors documentation.
• Excellent written, verbal, and presentation communication skills.
• Proven ability to influence stakeholders across multiple functional areas.
• Ability to work independently and make sound decisions with limited supervision.
• Experience managing external translation and localization vendors