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# Medical Device Design Quality Engineer

- **Company:** Manpower
- **Location:** Pittsburgh, PA, United States
- **Experience:** Experienced
- **Salary:** $76,960.0 - $87,360.0
- **Contract:** Permanent contract
- **Skills:** Adobe InDesign, Failure Mode Effects Analysis, Minitab, Verification and Validation (Software), Statistics Packages
- **Published:** October 26, 2026
- **Apply:** https://www.techcareers.com/job.asp?id=3467343487&tx=FR4744FFF&pt=1&aff=0B19D771-A501-4A5E-8338-2A822B784D54&utm_source=Job%20Feed&utm_medium=textkernel&utm_campaign=DE&utm_term=0B19D771-A501-4A5E-8338-2A822B784D54

## About the Role

* Bachelor's degree in Engineering, Quality, or a related field (Master's preferred).
 * 3+ years of experience in medical device quality engineering or a related field.
 * Strong knowledge of ISO 13485, FDA QSR (21 CFR Part 820), EU MDR, and risk management (ISO 14971).
 * Experience with Design Control, Process Validation, CAPA, and Supplier Quality.
 * Proficiency in statistical analysis tools (Minitab) and problem-solving methodologies (8D, DMAIC).

## Description

* Support design quality activities throughout new product development, including design reviews, requirements review, risk management, verification and validation planning, and design transfer readiness.
 * Lead and participate in Design Failure Modes and Effects Analysis (DFMEA) and risk assessments to identify and mitigate design and manufacturing risks.
 * Review protocols and participate in V&V planning to ensure alignment with product requirements and risk controls.
 * Support design transfer activities by ensuring product and process requirements are translated into manufacturing, inspection, supplier, validation, and release deliverables.
 * Manage and drive timely resolution of nonconformances (NCs) and corrective & preventive actions (CAPAs).