Pittsburgh Medical Device Design Quality Engineer

Experis Austria; Pittsburgh (Allegheny County); On-site; USD 51,000 - 58,000; Full time

Job summary

Experis Austria is seeking a Medical Device Design Quality Engineer to join our client’s Quality Assurance team in Pittsburgh. The role supports product development and manufacturing, focusing on design quality activities and risk management to ensure patient safety and regulatory compliance.

You will lead DFMEA, participate in V&V planning, manage CAPAs and NCs, and work with suppliers to translate design requirements into approved manufacturing deliverables.

Qualifications

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

Responsibilities

• Support design quality activities throughout new product development, including design reviews and risk management.
• Lead and participate in DFMEA and risk assessments to mitigate design/manufacturing risks.
• Review protocols and participate in V&V planning to ensure alignment with requirements.
• Support design transfer activities translating design requirements into manufacturing deliverables.
• Manage timely resolution of nonconformances and CAPAs.

Skills

DFMEA

CAPA

Design Control

Risk Management

Statistical Analysis

Minitab

Problem Solving

FDA QSR

Education

Bachelor's degree in Engineering/Quality or related

Master's preferred

Tools

Minitab

Job description

Experis Austria is seeking a Medical Device Design Quality Engineer to join our client’s Quality Assurance team in Pittsburgh. The role supports product development and manufacturing, focusing on design quality activities and risk management to ensure patient safety and regulatory compliance.

You will lead DFMEA, participate in V&V planning, manage CAPAs and NCs, and work with suppliers to translate design requirements into approved manufacturing deliverables.