Technical Writer

CoreMap’s mission is to improve the lives of people affected by atrial fibrillation. We are developing a highresolution, real-time, 3D electroanatomical mapping system for use during cardiac procedures to guide ablation therapy. Our system will generate novel maps of AF using advanced statistical analysis of data acquired from our ultra high-resolution cardiac catheter

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 CoreMap’s 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 CoreMap 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 CoreMap Quality Management System.

  • Collaborate with all CoreMap teams to gather cross-functional information and develop deep understanding of CoreMap 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

For inquiries or to submit your resume, email us at jobs@coremapmedical.com and reference the job posting in your email title.

Michelle DeJoie