Engineering - Prin Technical Writer : 24+ months : Onsite $60/hr

Job Description

Job Description

Principal Technical Writer

Hiring Manager’s Top Needs

1. Medical Devices experience (minimum 6 years) creating artwork files using Adobe Illustrator and InDesign in technical communication/technical writing/labeling development/content generation
2. SME knowledge of Instructions for Use (IFU) and other labeling content requirements
3. Labeling Standards and Regulations expertise

Education Required

Master's in regulatory or any engineering field

Position Overview

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
  • 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.
• 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

Responsibilities may include the following and other duties may be assigned.

• Creates, develops, plans, writes and edits operational, instructional, maintenance or test procedures for paper, multimedia, webbased publications and user sites; may produce content for embedded user assistance technology.
• Conducts interviews with various users and technical staff to gather data for documentation.
• Researches and translates technical information into manuals and/or webbased documents for nontechnical and technical users.
• May document engineering processes and specifications.
• Recommends formats responsive to technical and customer requirements.
• Produces products that conform to the company documentation and quality assurance standards.

\nCompany Description

LanceSoft is rated as one of the largest staffing firms in the US by SIA. Our mission is to establish global cross-culture human connections that further the careers of our employees and strengthen the businesses of our clients. We are driven to use the power of our global network to connect businesses with the right people, and people with the right businesses without bias. We provide Global Workforce Solutions with a human touch.

Company Description

LanceSoft is rated as one of the largest staffing firms in the US by SIA. Our mission is to establish global cross-culture human connections that further the careers of our employees and strengthen the businesses of our clients. We are driven to use the power of our global network to connect businesses with the right people, and people with the right businesses without bias. We provide Global Workforce Solutions with a human touch.