Design Quality Engineer

We are seeking a Design Quality Engineer with strong experience in Design History File (DHF), Risk Management, and Medical Device Documentation. Support DHF remediation, engineering change documentation, audits, compliance activities, and continuous process improvement.

Title: Design Quality Engineer / DHF Documentation Engineer
Location: Indianapolis, IN
Duration: 6 Months

Job Summary:
We are seeking a Design Quality Engineer with strong experience in Design History File (DHF), Risk Management, and Medical Device Documentation. The ideal candidate will support product development by maintaining DHF documentation, risk management files, design control documentation, and ensuring compliance with FDA/ISO quality standards throughout the product lifecycle.
Required Skills:

• Design History File (DHF)
• dFMEA & uFMEA
• Preliminary Hazard Analysis (PHA)
• Risk Management Documentation
• Product Specification Documents (PSD)
• Critical-to-Quality (CTQ)
• Design Inputs, Design Outputs, Verification & Validation
• Traceability Matrix & Design Controls
• Medical Device Documentation
• Cockpit Cognition (preferred)
• Engineering Change Management
• Regulatory & Quality Compliance

Responsibilities:

• Review, update, and maintain DHF, dFMEA, uFMEA, PHA, PSD, and CTQ documentation.
• Ensure traceability between user needs, design inputs/outputs, risk controls, verification, and validation activities.
• Collaborate with Design, Quality, Regulatory, Manufacturing, and Project teams to support product development.