Technical Writer

Our organization is dedicated to improving outcomes for patients with complex cardiac rhythm disorders. We are developing an advanced, real-time three-dimensional mapping system used during electrophysiology procedures to support therapeutic ablation. By combining high-resolution data from proprietary sensing technologies with advanced computational analysis, our platform delivers enhanced clinical insight and diagnostic precision.

The Opportunity

The Technical Writer will play a critical role in ensuring the accuracy, consistency, and regulatory compliance of medical device quality documentation. This position focuses heavily on authoring and maintaining technical documentation aligned with U.S. pre-market regulatory pathways, including 510(k) and De Novo submissions. The role serves as a key liaison across hardware, software, and mechanical engineering teams, translating complex technical concepts into clear, structured documentation that meets internal and regulatory standards.

This is a full-time, on-site position based in Burlington, MA.

Core Responsibilities

• Design Control Ownership: Act as a subject matter expert for the Design Control process, ensuring documentation provides clear, traceable objective evidence suitable for regulatory review.
• Documentation Development: Author, revise, and manage technical documents such as SOPs, manufacturing work instructions, test protocols, and reports within the Quality Management System (QMS).
• Cross-Functional Collaboration: Work closely with engineering and R&D teams to gather, interpret, and document complex technical and process-related information.
• Technical Investigation: Research and formalize engineering workflows, system requirements, performance specifications, and development protocols.
• Document Structure & Usability: Recommend and implement improvements to document formatting, structure, and lifecycle management to enhance clarity, usability, and compliance.
• Quality & Compliance Assurance: Ensure all documentation meets high standards for technical accuracy, regulatory compliance, and patient safety.
• Engineering & R&D Support: Provide documentation support for ongoing engineering and development activities as needed.
• Culture of Quality: Foster a culture of transparency, continuous improvement, and patient-first thinking across documentation practices.

Qualifications & Experience

• Education: Bachelor’s degree in Engineering or a Scientific discipline required.
• Industry Experience: Minimum of 4 years of experience in the medical device industry.
• Regulatory Expertise: Proven experience authoring documentation supporting Class II or Class III pre-market regulatory submissions.
• Communication Skills: Exceptional written and verbal communication skills with strong attention to detail and technical accuracy.
• Adaptability: Ability to thrive in a fast-paced, growth-oriented environment while maintaining rigor within a regulated quality system.