Principal Engineering Technical Writer

ATR International; Irvine (CA); On-site; USD 110,000 - 170,000; Full time

Job summary

ATR International is seeking a Principal Technical Writer in Irvine, CA to lead labeling development for neurovascular medical devices. You will produce IFUs, user guides, electronic labeling, and packaging artwork, translating complex regulatory information into clear, user-focused content for clinicians, healthcare professionals, and patients.

The role requires 6+ years in medical devices labeling/technical writing, strong regulatory knowledge, and hands-on experience with InDesign and

Qualifications

• 6+ years in medical devices labeling and technical writing.
• Experience translating regulatory requirements into user-friendly content.
• Understanding of labeling standards and regulatory expectations.

Responsibilities

• Lead end-to-end labeling development (IFUs, user guides, electronic labeling).
• Ensure regulatory and quality compliance across global standards.
• Collaborate with R&D, Regulatory Affairs, QA, and Marketing to align content.

Skills

Medical devices experience

Technical writing

Labeling development

Adobe InDesign

Adobe Illustrator

Regulatory knowledge

Education

Master's in regulatory or engineering

Tools

Adobe InDesign

Adobe Illustrator

Content management systems

Job description

The Principal Technical Writer leads the development and lifecycle management of customer-facing medical devices, labeling content and artwork for neurovascular medical devices, including Instructions for Use (IFUs), user guides, electronic labeling, and preprinted packaging materials. This role translates complex technical and regulatory information into clear, accurate, user-focused content for healthcare professionals, clinicians, and patients. Working across new product development and sustaining initiatives, the position ensures labeling deliverables meet global regulatory requirements, design control expectations, quality standards, and business objectives.

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 but not limited to 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.

Required Skills & Qualifications:

• 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

Education Required:

Master's in regulatory or any engineering field.

Full-time employees (working an average of 30 hours or more) are eligible to select from different benefits packages. Packages may include medical, dental, and vision benefits, a 401(k) retirement savings plan with employer match (available after 1 year of employment), commuter benefits, employee discount and referral programs, and life and supplemental income insurance. Paid sick leave is provided in accordance with applicable state and local laws.

Compensation

Final offer amounts, within the base pay set forth above, are determined by factors including your relevant skills, education, and experience, as well as the benefits package you select.

Work Authorization

ATR International, Inc. cannot sponsor work visas (H-1B, F-1 STEM OPT with I-983, or similar). Candidates must have valid U.S. work authorization.

ATR International, Inc. is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.