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# Medical Device Design Quality Engineer

- **Company:** Experis
- **Location:** Pittsburgh, PA, United States
- **Experience:** Experienced
- **Salary:** $76,960.0 - $87,360.0
- **Contract:** Permanent contract
- **Skills:** Minitab, Statistics Packages
- **Published:** August 28, 2026
- **Apply:** https://www.experis.com/en/job/409549/medical-device-design-quality-engineer

## About the Role

Our client, a leading organization in the medical device industry, is seeking a Medical Device Design Quality Engineer to join their team. As a Medical Device Design Quality Engineer, you will be part of the Quality Assurance department supporting product development and manufacturing teams. The ideal candidate will demonstrate strong analytical skills, attention to detail, and a proactive mindset, which will align successfully in the organization., + 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).
What's Needed?


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