Design Quality Engineer

Thunderhawk Technology Partners LLC

Indianapolis, IN
6 days ago

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Skills

Design Failure Mode and Effects Analysis (DFMEA)unmatched
Design Verificationunmatched
Document Managementunmatched
Documentationunmatched
Engineering Change Managementunmatched
FDA (Food and Drug Administration)unmatched
Hazard Analysisunmatched
ISO (International Organization for Standardization)unmatched
Maintain Complianceunmatched
Manufacturing Requirementsunmatched
Medical Equipmentunmatched
Process Hazard Analysis (PHA)unmatched
Process Improvementunmatched
Product Developmentunmatched
Product Lifecycleunmatched
Product Supportunmatched
Quality Engineeringunmatched
Quality Metricsunmatched
Regulatory Complianceunmatched
Risk Managementunmatched
Technical/Engineering Designunmatched
Traceabilityunmatched
Validation Testingunmatched

Description

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.

Support DHF remediation, engineering change documentation, audits, compliance activities, and continuous process improvement.

Numbers & Facts

Location

Indianapolis, IN

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