Technical Writer

We are seeking an experienced Technical Writer to support the Design Assurance team in developing and maintaining documentation for medical device product development. The ideal candidate will translate complex engineering data into clear, compliant technical documents to support regulatory submissions, audits, and product lifecycle milestones.

Key Responsibilities

Develop, review, and maintain design verification reports, test protocols, and risk management documentation.

Translate engineering and scientific data into accurate, concise, and compliant technical content.

Ensure all documentation aligns with FDA, ISO, and internal design control requirements.

Manage document reviews, approvals, and updates within the Quality Management System (QMS), including Windchill or similar PLM systems.

Support risk management activities including DFMEA / PFMEA updates, traceability matrices, and mitigation documentation.

Collaborate with R&D, Quality, and Engineering teams to ensure proper alignment on design inputs, testing, and product risk controls.

Contribute to design control deliverables for products progressing through clinical development toward commercialization.

Qualifications

3–5 years of experience as a Technical Writer in the medical device, biotech, or regulated hardware industry.

Strong technical understanding of engineering concepts and ability to interpret testing data.

Hands-on experience writing technical protocols, reports, and controlled documentation.

Knowledge of FDA 21 CFR 820, ISO 13485, and design control standards.

Experience with document control and PLM systems (e.g., Windchill).

Seniority level

Not Applicable

Employment type

Contract

Job function

Writing / Editing

Industries : Medical Equipment Manufacturing

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