Technical Writer

Burlington, MA, US • Posted 30+ days ago • Updated 10 days ago

Full Time

On-site

Depends on Experience

Fitment

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Job Details

Skills

Medical Devices
Technical Writing

Summary

The Technical Writer will ensure the clarity, accuracy and quality of our medical device quality documents, ensuring compliance with US pre-market regulatory submission requirements (e.g., FDA 510(k), De Novo). The Technical Writer will collaborate across hardware, software, and catheter development teams to document complex technical information in accordance with procedures and standards. This role is based full-time in our Burlington, MA office.
Responsibilities

Act as a subject matter expert in the application of the Design Control process including the creation of objective evidence to demonstrate compliance.
Create, develop, plan, write, and edit procedures, work instructions, manufacturing procedures, and test procedures in accordance with the Quality Management System.
Collaborate with all teams to gather cross-functional information and develop deep understanding of operations, compliance system, regulated processes, business systems and technology.
Research and document engineering processes, product specifications, and development protocols.
Recommend and implement documentation format improvements.
Ensure all content meets established quality, usability, and regulatory standards.
Willingness to support engineering activities as required.
Foster a culture of trust, open communication, and continuous improvement, with an unwavering focus on advancing patient outcomes.

Skills and Experience

B.A. in a related Engineering or Science discipline is required.
4+ years working for a medical device company.
Significant experience preparing technical documentation for pre-market regulatory submissions
Excellent verbal and written communication skills with attention to detail.

Comfortable working in both a rigorous early-stage environment with fluid requirements, as well as a regulated later-stage process-driven setting is required

Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.

Dice Id: 10410688
Position Id: 3706
Posted 30+ days ago

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