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Engineering Technical Writer (Temporary) (San Diego, CA)
The Temporary Engineering Technical Writer is the interface between Engineering and Document Control. Furthermore, the position requires a strong emphasis of medical device quality system. The Temporary Engineering Technical Writer applies a multidisciplinary approach to ensure technical needs are translated into step-by-step processes. The Temporary Engineering Technical Writer works closely with all facets of engineering, as well as with the usability, regulatory, manufacturing, and quality functional areas to ensure alignment with cross functional teams to release documents in a timely manner. The Temporary Engineering Technical Writer is integral in. The Temporary Engineering Technical Writer is the point person for ensuring documentation relating to engineering changes is reviewed, updated and finalized.
Essential job functions and duties
Essential job functions and duties
- Review validation protocols and reports for technical accuracy and formatting
- Evaluate datasheets to ensure compliance with acceptance criteria.
- Access content in reports for GMP compliance.
- Create, organize, and edit user guides, manuals, and other technical publications related to biotech products and engineering processes
- Manage and document change orders, ensuring all modifications are accurately reflected in the technical documentation.
- Ensure all documents adhere to company standards and formatting guidelines, including compliance with industry-specific regulations.
- Review and edit prepared documents for clarity, grammatical accuracy, and proper formatting
- Analyze variable data using Minitab to ensure it meets the required confidence and reliability limits.
- Review and implement changes requested by the cross-functional reviewing team.
- Understands the impact on any change and writes assessments accordingly.
- Perform other duties as assigned.
- Bachelor’s degree in Systems, Electrical, Computer, Biomedical or Mechanical Engineering and a minimum 3 years of related experience; or an equivalent combination of education, training and/or experience from which comparable knowledge, skills and abilities have been attained.
- Experience in the medical device regulated industry based on ISO 13485.
- Strong skills in word processing and documentation software (e.g., Microsoft Office, Adobe Acrobat), and familiarity with biotech and engineering terminology and concepts.
- Above average ability to relay technical information orally and write clear and concise documents for review by regulatory agencies.
- Good documentation, recordkeeping and data collection skills with attention to detail.
- Understanding statistical sample size techniques to determine the appropriate amount of test samples.
- Excellent communication and interpersonal skills, with the ability to translate complex scientific and engineering information into clear, concise, and user-friendly documentation.
- Excellent teamwork and interpersonal skills.
- Ability to work with minimal supervision.
- Familiarity with automated PLM tools e.g. Polarion is a plus.
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