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# Design Quality Engineer

- **Company:** Intellectt, Inc
- **Location:** Boston, MA, United States
- **Experience:** Expert
- **Salary:** $93,600.0 - $99,840.0
- **Contract:** Permanent contract
- **Skills:** Code Review, Software Engineering, Software Requirements Analysis
- **Published:** October 8, 2026
- **Apply:** https://www.careerjet.com/jobad/us23ab2e4a0dfed7bf33b9adab69eaac8b

## About the Role

* 3 5+ years of Medical Device experience.
 * Design Quality Engineering.
 * SaMD / Medical Device Software.
 * Software Design Controls.
 * Software Risk Management.
 * Verification & Validation.
 * IEC 62304, ISO 13485 and ISO 14971.
 * Bachelor's degree.

Preferred: ASQ Software Quality Engineer certification.

## Description

We are seeking a Design Quality Engineer with strong Medical Device Software / SaMD experience to provide quality oversight for new product development. This role will partner closely with R&D teams throughout software design, development, verification, risk management, and regulatory compliance activities., * Provide Design Quality oversight for Medical Device Software and SaMD products.

 * Support software requirements, architecture/design reviews, and design controls.
 * Facilitate software risk assessments and maintain risk documentation.
 * Review verification activities, test results, code reviews, and software defects.
 * Support CAPA, non-conformances, root cause investigations, audits, and regulatory submissions.
 * Ensure compliance with IEC 62304, ISO 13485, ISO 14971, 21 CFR Part 11, FDA requirements, and EU MDR