Job #10260: Technical Writer
Title: Technical Writer
Date Posted: 06/04/2018
Job Location: MA
I. Position Overview
As a part of the Quality and Product Development teams, the Technical Writers will be responsible for using the inputs from the engineering staff to write technical documents. Responsibilities include developing the content and format of Medical Device Design History File (DHF) documents such as Design Development Plans, Verification/Validation Plans and Protocols, Risk Assessments, Trace Matrices, Requirement/Specifications, etc. in a fast-paced, start-up environment where all work is subject to government (U.S. FDA) and industry (ISO) regulations and standards.
II. General Responsibilities
• Write DHF documents such as Design Development Plans, Verification/Validation Plans and Protocols, Risk Assessments, Trace Matrices, Requirement/Specifications
• Develop document templates
• Update and/or edit existing documents.
• Attend design project team meetings to collect technical data for use in creating documents
• Apply technical writing standards and, style and format norms to create effective technical documentation.
III. Specific Responsibilities
Take technical inputs from the engineering staff and create technical documents in compliance with government regulations, industry standards and company requirements.
• Must be able to read, write and communicate fluently in English.
• The employee in this position often communicates with employees and vendors who have inquiries, therefore must be able to read, write and communicate to exchange correct information in these situations.
IV. Position Requirements
To perform this job successfully, the candidate must be able to perform each essential duty satisfactorily; training will be provided as needed. The requirements listed below are representative of the knowledge, skill, and / or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions, or to train technically-competent individuals in company specific software
• 2-3 years of medical device technical writing experience
• Demonstrated skills in technical writing; grammar and usage, form, organization of ideas, technical communications.
• Ability to manage multiple documentation projects in a fast-paced environment.
• Strong time management skills. Meeting deadlines is a must.
• Mastery of MSWord software.
• Bachelor's Degree in a related discipline.
• Experience writing design control documents in a medical device setting
• Comfortable in a startup environment where process and role structure are frequently missing or changes rapidly.
• Design Control Documentation (FDA DHF) experience.
V. Physical Requirements
• Position routinely requires filing, which will require opening file cabinet drawers, being able to bend for file placement.
• The position often needs objects be moved from one place to another under 15 pounds lifting periodically must move objects.
• Employee must have the visual acuity to determine the accuracy, neatness, and thoroughness of the work assigned.
• The employee is required to have close visual acuity to inspect products perform, analyze data and numbers, view a computer terminal; extensive reading at a distance that is close to the eyes.