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# Design Quality Engineer - Software Focus

- **Company:** Intellectt, Inc
- **Location:** United States
- **Salary:** $99,840 - $108,160
- **Contract:** Temporary to permanent
- **Skills:** Testing (Software), Software Quality, Failure Mode Effects Analysis, Software Product Management, Software Tools, Software Requirements Analysis, Software Verification
- **Published:** October 27, 2026
- **Apply:** https://www.careerbuilder.com/job-details/design-quality-engineer-software-focus-ma--7246e0ee-c023-49d8-99be-7edc996e49db

## About the Role

Quality Engineering, Technical/Engineering Design, Quality Engineering, Engineering Software, Technical/Engineering Design, Medical Equipment, Project/Program Management, Documentation, Risk Management, Regulatory Submissions, Medical Device Software Quality: Direct experience supporting design quality or design assurance for software used in a regulated medical device.
Design Controls and DHF: Experience reviewing design inputs/outputs, design documentation, and DHF records across development or sustaining projects.
Software Verification and Validation: Experience reviewing software test protocols, results, and requirements-to-test traceability, and identifying gaps or unresolved issues.
Risk Management: Experience with medical device risk assessments and FMEAs, including evaluating the effect of software or design changes on device safety and performance.
Change Control and Quality Investigations: Ability to assess design change impacts and support related documentation, investigations, CAPA, and design transfer activities.
Regulated Development: Working knowledge of medical device design controls and quality/risk management processes, including FDA requirements, ISO 13485, and ISO 14971.
Communication and Execution: Ability to work independently, manage multiple priorities, follow through on commitments, and communicate progress and availability consistently.
Benefits: This a contract position does not include employer-provided benefits., Applicants must be authorized to work in the United States

## Description

We are seeking a Design Quality Engineer to support medical device development and sustaining projects, with a primary focus on product software. The engineer will help maintain design controls and risk management documentation, review software requirements and verification/validation evidence, and support traceability and Design History File (DHF) completeness. The role will work with R&D, Manufacturing, Regulatory, and Project Management to assess design changes, resolve quality issues, and support design transfer and regulatory submission readiness. The ideal candidate can take ownership of assigned work in a fast-paced environment, identify documentation gaps, and communicate clearly across functions.