Medical Device Technical Writer Job at Mastech Digital, Newark, NJ

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  • Mastech Digital
  • Newark, NJ

Job Description

The Technical Writer II will develop, design, and manage instructional and informational documentation for medical devices, ensuring safety, effectiveness, and compliance. This role requires expertise in creating work instructions, SOPs, and manuals, with a focus on electromechanical assembly processes. The writer will collaborate with operators, troubleshoot technical content, and handle document revisions through Agile and change management systems like EDMS/Agile.

Key Responsibilities :

  • Develop and update technical documentation, including SOPs, work instructions, and guidelines for medical devices.
  • Collaborate with operators to revise documents based on hands-on observations.
  • Manage documentation projects, ensuring timely delivery and adherence to quality standards.
  • Troubleshoot instrumentation and assays to improve content and accuracy.
  • Coordinate and lead document reviews and manage translation projects.
  • Maintain consistency in documentation across product lines and processes.
  • Follow FDA regulations and ISO requirements in all documentation.

Qualifications :

  • Experience : Experience in technical writing, preferably in medical devices or pharma.
  • Skills : Proficient in MS Word, Agile, and experience with PLM systems. Strong communication and collaboration skills.
  • Education : College degree (Technical degree preferred).

Preferred :

  • Experience in medical devices and knowledge of GDP and SOPs.
  • Familiarity with PLM systems, and source control tools like GitHub.

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