Engineering - Prin Technical Writer - Exempt

Join our dynamic team in Irvine, CA, a vibrant hub for innovation and technology. We are seeking a seasoned professional to lead the development and lifecycle management of customer-facing medical device labeling content and artwork. This role is pivotal in translating complex technical and regulatory information into clear, accurate, user-focused content for healthcare professionals, clinicians, and patients.

Key Responsibilities

• Labeling Development: Lead the end-to-end creation, revision, and optimization of IFUs, user guides, electronic labeling, and preprinted packaging artwork from concept through final release using Adobe Indesign, Illustrator, content management, and other tools and technology.
• Content Strategy: Define documentation and artwork requirements, gather cross-functional inputs, and translate complex technical information into accurate, accessible content for technical and nontechnical users.
• Regulatory and Quality Compliance: Ensure labeling conforms to applicable global regulations and standards, including FDA, EU MDR, IMDRF, UDI, IEC60601, ISO20417, ISO15223, as well as internal quality management system requirements.
• Cross-Functional Leadership: Partner with R&D, Regulatory Affairs, Quality, Marketing, Medical Safety, Clinical, and other stakeholders to align content, resolve issues, and deliver labeling milestones on schedule.
• Risk and Change Management: Assess compliance gaps and implementation risks, lead Change Orders and design control deliverables, and maintain substantiation, traceability, review, and verification documentation.
• Lifecycle Management: Support product launches, sustaining activities, and legacy document maintenance while driving standardization, version control, and compliant implementation across the labeling lifecycle.
• Regulatory Intelligence: Monitor evolving regulatory requirements and provide timely, practical guidance to project teams and leadership.

Additional Responsibilities

• Create, develop, plan, write, and edit operational, instructional, maintenance, or test procedures for paper, multimedia, web-based publications, and user sites.
• Conduct interviews with various users and technical staff to gather data for documentation.
• Research and translate technical information into manuals and/or web-based documents for nontechnical and technical users.
• Document engineering processes and specifications.
• Recommend formats responsive to technical and customer requirements.
• Produce products that conform to the company documentation and quality assurance standards.

Required Knowledge and Experience

• Mastery of a specialty area and full knowledge of industry practices, typically obtained through advanced education combined with experience.
• Advanced degree with a minimum of 5 years of relevant experience, or a University Degree and a minimum of 7 years of relevant experience.
• Medical Devices experience (minimum 6 years) creating artwork files using Adobe Illustrator and Indesign in technical communication/technical writing/labeling development/content generation.
• SME knowledge of Instructions for Use (IFU) and other labeling content requirements.
• Labeling Standards and Regulations expertise.