Technical Writer

Position Summary

This position is responsible for the origination, editing and revision of technical documentation including component specifications and manufacturing standard operating procedures. With appropriate input from other disciplines, this position may also be responsible for the editing and revision of technical reports or regulatory submission documents.

Minimum Qualifications

• Bachelor’s degree in English, business or a technical field, or equivalent.
• At least two to three (2-3) years of industry experience in either procedure writing, technical writing, or engineering.
• Master’s degree in English, business or a technical field or equivalent.
• Experience in the medical device industry.
• Experience in continuous improvement projects- documentation best practices and improvements.
• Familiarity with enterprise resource planning systems (ERP) and electronic document management systems (EDMS) (e.g. MFGPro, JDE, and MasterControl).

Essential Duties & Responsibilities

The following duties and responsibilities are intended to be representative of the work performed by the incumbent(s) in this position and are not all-inclusive. The omission of a specific duty or responsibility will not preclude it from the position.

• Creates and ensures that the various types of documentation are accurate, readable, well organized and geared toward the intended user of the documentation.
• Applies skills and develops documentation including: customer facing literature, operating procedures, component specifications, process flow charts and manufacturing procedures.
• Assists engineering functions in gathering, organizing and formatting information for inclusion in feasibility, qualification or validation reports.
• Creates and submits new documents or document revisions into the document control system and tracks them to release.
• Advises and participates in process review of the manufacturing process in order to develop or modify manufacturing documentation.
• Prepare and participate in device master record (DMR) reviews, under the direction of a Senior Technical Writer or designee, for product development teams.
• Assists functions in gathering information for, organizing, formatting and writing domestic and international documents. Participates as an active team member in cross functional teams.

Knowledge & Skills

• Excellent written and verbal skills.
• Ability to communicate with all levels of technical and operations personnel.
• Ability to complete position responsibilities with limited direct supervision.
• Ability to gather and organize information.
• Ability to grasp technical terms, processes and methods.
• Ability to handle a variety of projects at the same time.
• Excellent Microsoft Word skills along with ability to navigate Bard computer systems.
• Familiarity with electronic documentation management (EDM) systems and their function and use.
• Ability to work in a cross-functional team environment, as well as the ability to function independently.

Physical Requirements

This position is in an office and laboratory environment and requires the incumbent to sit, stand and perform general office functions. The incumbent may also be required to lift up to twenty-five pounds occasionally. The incumbent may be required to stand for extended periods of time. Bending, stooping and reaching are also frequently required.