Engineering Technical Writer

Responsibilities

• Responsible for creating, editing, and maintaining technical documentation that supports the design, manufacturing, and quality systems of medical devices. This role ensures that all documentation is clear, accurate, compliant with regulatory standards, and accessible to internal teams and external stakeholders.
• Develop, write, edit, and maintain technical documents including Standard Operating Procedures (SOPs), Work Instructions, Device Master Records (DMR), Device History Records (DHR), validation protocols, and technical reports.
• Collaborate with engineering, quality assurance, manufacturing, and regulatory teams to gather technical information and convert complex concepts into clear, concise documentation.
• Ensure documentation complies with applicable regulatory requirements including FDA regulations, ISO 13485 standards, and Good Manufacturing Practices (GMP).
• Maintain document control procedures, ensuring proper version control, formatting consistency, and document approval workflows in accordance with company policies.
• Support the preparation and maintenance of documentation required for audits, regulatory submissions, and quality system compliance.
• Review and revise existing documentation to ensure accuracy, clarity, and alignment with updated processes, equipment, or regulatory changes.
• Assist in developing user manuals, training materials, technical guides, and product documentation for internal and external use.
• Work with cross-functional teams to ensure documentation accurately reflects manufacturing processes, product specifications, and quality requirements.
• Support continuous improvement initiatives by documenting process improvements and ensuring updated procedures are properly communicated and implemented.
• Perform any other related duties as assigned.

Minimum of 2–4 years of experience in technical writing within a regulated industry, preferably in medical device manufacturing.

• Strong understanding of documentation requirements for FDA-regulated environments and ISO quality management systems.
• Experience writing technical documentation such as SOPs, validation reports, engineering documents, and manufacturing procedures.
• Excellent writing, editing, and proofreading skills with the ability to translate complex technical information into clear and understandable content.
• Strong organizational and document management skills.
• Proficiency in Microsoft Office applications (Word, Excel, PowerPoint) and familiarity with document control systems.
• Strong interpersonal and communication skills with the ability to collaborate effectively with engineering, quality, manufacturing, and regulatory teams.

• Bachelor's degree in Technical Writing, Engineering, Life Sciences, Communications, or a related field is preferred.
• Equivalent experience in technical documentation within the medical device, pharmaceutical, or regulated manufacturing industry may substitute for formal education.

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• Work performed in an office and factory settings.
• Ability to manage multiple priorities.
• Regularly required to sit, stand, and move around facilities.