Job Title: Technical Writer (Medical Systems)

Work Location: Middlesex County, Massachusetts

Summary:

The Technical Writer is responsible for the precision, integrity, and quality of medical device quality documentation. A primary focus of this role is ensuring that all technical materials align with stringent US pre-market regulatory frameworks (such as 510(k) and De Novo pathways). This position serves as a central hub between hardware, software, and mechanical engineering teams to translate intricate technical details into formal documentation that adheres to established internal standards.

Responsibilities:

• Design Control Expert: Serve as a specialist in the execution of the Design Control lifecycle, ensuring all documentation provides the necessary objective evidence for regulatory scrutiny.
• Procedural Development: Draft, refine, and manage a suite of technical documents, including standard operating procedures (SOPs), manufacturing work instructions, and rigorous test protocols within the company’s Quality Management System (QMS).
• Cross-Functional Synergy: Partner with multidisciplinary engineering units to synthesize complex operational data and gain a comprehensive understanding of regulated processes and underlying technology.
• Technical Research: Investigate and formalize engineering workflows, product performance specifications, and R&D protocols.
• Format Optimization: Proactively suggest and execute improvements to document architecture to enhance usability and compliance.
• Quality Assurance: Verify that all technical content satisfies high standards for clarity, regulatory alignment, and clinical safety.
• Engineering Support: Provide auxiliary support to R&D and engineering tasks as needed to maintain project momentum.
• Professional Culture: Promote an environment of transparency and continuous improvement, keeping patient safety at the center of all documentation efforts.

Qualifications:

• Education: A Bachelor’s degree in an Engineering or Scientific field is required.
• Industry Tenure: At least 4 years of experience specifically within the medical device sector.
• Regulatory Expertise: Demonstrated success in authoring technical documentation for Class II or Class III pre-market regulatory submissions.
• Communication Mastery: Exceptional writing and verbal skills with a meticulous eye for detail and technical accuracy.
• Adaptability: Ability to navigate the fluid requirements of a high-growth startup while maintaining the discipline required for a strictly regulated, process-driven environment.

Published Category: Medical Writing