Medical Device Technical Writer

Gem Care, Inc.; Oak Ridge (TN); On-site; USD 60,000 - 85,000; Full time

Job summary

Gem Care, Inc. in the Oak Ridge/Knoxville, TN area seeks an experienced Technical Writer to document design verification activities, engineering reports, and manufacturing procedures.

You will contribute to rigorous record-keeping for regulatory medical device compliance and collaborate with engineering teams to produce clear, compliant documentation. The role requires at least 2 years in a similar setting, proficiency with Word, Excel, and Adobe Acrobat, and the ability to tailor content for

Qualifications

• Minimum 2 years of experience as a technical writer in a manufacturing or engineering environment.
• Experience writing clear, precise documentation for diverse audiences (auditors, technicians, engineers).
• Ability to learn quickly, synthesize complex engineering concepts, and translate them into accessible documentation.
• Experience working with engineers and managing multiple projects with high attention to detail.

Responsibilities

• Design & Compliance Documentation: document project plans, design inputs/specs, design reviews, design outputs, and V&V activities.
• Testing & Verification Support: outline verification strategies and develop detailed test steps for requirements.
• Reports & Publications: prepare and release engineering technical reports using standard templates.
• Visual Asset Management: build and maintain a library of reference images and schematics.
• Procedure Development: create and revise manufacturing and service procedures using technical data from SMEs.

Skills

Technical Writing

Regulatory Compliance

Documentation Standardization

Audience Adaptability

Project Management

Collaboration

Education

Bachelor's degree in Technical Writing / English / Engineering

Tools

Microsoft Word

Excel

Adobe Acrobat

Job description

Gem Care, Inc. in the Oak Ridge/Knoxville, TN area seeks an experienced Technical Writer to document design verification activities, engineering reports, and manufacturing procedures.

You will contribute to rigorous record-keeping for regulatory medical device compliance and collaborate with engineering teams to produce clear, compliant documentation. The role requires at least 2 years in a similar setting, proficiency with Word, Excel, and Adobe Acrobat, and the ability to tailor content for