JOB SUMMARY
The Technical Writer develops, writes, and edits material for customer manuals, release notes, submissions, clinical documentation, web content, sales collateral, and internal procedures as required. The writer must be able to effectively “translate” highly technical information into end-user-appropriate language without sacrificing technical accuracy. The writer will utilize functional specifications, access medical equipment, and interface with engineers, surgeons, and other subject matter experts to develop content. The technical writer ensures that documents meet the company’s high standards for technical and regulatory accuracy, clarity, tone, and style while adhering to aggressive timelines. The writer must also be an experienced project manager, able to represent their area on cross functional teams while managing multiple writing projects simultaneously.

DUTIES & RESPONSIBILITIES
Plan, develop, write, and edit user manuals and other instructions for use (IFUs).

• Create and maintain labels per corporate, regulatory, and global standards and in coordination with various internal experts.
• Execute necessary Change Orders or other processes in compliance with quality system guidelines

Maintain traceability between risk analysis, usability studies, and other internal findings and IFUs.
Coordinate documentation planning with product teams; understand strategies, priorities, and timelines of internal collaborators.
Work with other stakeholders to adjust Technical Publications projects as necessary to support product development, sustaining product support, and corporate strategies.
Analyze existing documents to facilitate efficient content reuse and maintain continuity of style.
Upon request, compose reports, presentations and other comprehensive materials that provide accurate information clearly and concisely.

• Follow industry standards and best practices for FDA and CE regulatory compliance

Support and contribute to the development and maintenance of web content and sales collateral.
SUPERVISORY RESPONSIBILITIES

• N/A

QUALIFICATIONS
Required Qualifications
Bachelor’s degree in relevant field.
Minimum five (5) years’ experience within the medical device industry writing/editing scientific/medical material, or equivalent.
Intermediate to advanced experience with Adobe CC.
Intermediate to advance knowledge of Word, PowerPoint, and other Microsoft tools.
Excellent oral/written communication, research, and interpersonal skills required.
Excellent project management skills, including participation on cross-functional teams.
Detail-oriented, with the ability to ask succinct clarifying questions and to follow directions precisely.
Excellent organizational, analytical, and problem-solving skills.
Able to work independently on multiple tasks to create high quality outputs under changing and/or tight timelines.
Demonstrated experience working with Subject Matter Experts (SMEs) and a strong engineering acumen with the ability to read and decipher specs, blueprints, and other technical documents to create end-user-friendly procedures.
Knowledgeable about Good Manufacturing Practices (GMP) and applicable Quality System Standards.
Preferred Qualifications

• Demonstrated experience with project management tools and their application.
• Visual/graphic design skills and comfort turning source materials into interactive, visually appealing, and engaging multimedia content.

Orthopedic and/or medical device experience a strong plus.
COMPETENCIES
Technical Learning
Problem Solving
Planning
Perspective
Written Communication
Self-Knowledge

PHYSICAL DEMANDS & WORK ENVIRONMENT

• Must be able to remain in a stationary position and operate office equipment for a prolonged period.
• Physical activities include, but not limited to constant manual dexterity, moving about the work site, and/or handling objects weighing up to 20 lbs.
• Other infrequent physical activities include, but not limited to, positioning self to complete assigned tasks, and ascending/descending floors and/or ladders.
• Occasionally work around moving mechanical parts.
• Must be able to work a schedule that is commensurate with business operations, including work during weekends, holidays and/or times outside of normal business hours.
• Must be able to travel as business necessitates (up to 10 % Travel).

Disclaimer:
The above is intended to describe the general content of and requirements for the performance of this job. It is not to be construed as an exhaustive statement of duties, responsibilities, or physical requirements. Nothing in this job description restricts management’s right to assign or reassign duties and responsibilities to this job at any time. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

THINK Surgical, Inc. also participates in E-Verify, a web-based system that allows THINK to confirm an employee’s eligibility to work in the United States.

Actual compensation offered will depend on several factors including but not limited to geographic location, work experience, education, skill level, and/or other business and organizational needs. Base pay is one part of compensation, and this role may be eligible for discretionary bonuses/incentives and stock option grants.

Job Type: Full-time

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