Design History File Documentation Consultant

We are seeking experienced DHF Documentation Consultants to support medical device design and development activities. This role will focus on the creation, remediation, and maintenance of Design History File (DHF) documentation in compliance with FDA and applicable regulatory standards. Consultants will work cross-functionally with engineering, quality, and regulatory teams to ensure robust, audit-ready design documentation.

• Develop, review, and remediate Design History File (DHF) documentation in accordance with FDA 21 CFR 820 and ISO 13485
• Create and update Design FMEA (DFMEA) and Risk Management (FMEA) documentation
• Support 510(k) submissions by preparing and aligning design documentation
• Review and interpret engineering drawings and specifications, including GD&T (Geometric Dimensioning & Tolerancing)
• Ensure traceability between design inputs, outputs, verification, and validation
• Collaborate with R&D, Quality, Regulatory, and Manufacturing teams
• Support internal and external audits related to design controls and DHF content

• 5–10 years of experience in medical device documentation or design controls
• Strong hands‑on experience with DHF documentation
• Proven experience with DFMEA and FMEA
• Solid understanding of GD&T
• Direct experience supporting FDA 510(k) submissions
• Strong knowledge of FDA design control requirements and ISO standards
• Excellent documentation, communication, and organizational skills

• Experience in DHF remediation or audit response
• Background in regulated medical device environments
• Ability to work independently and manage multiple documentation streams