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

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.

Job Title: Medical Device Design Quality Engineer

Location: Pittsburgh, PA (Onsite)

Pay Range: $37-$42/Hr. on W2

What's the Job?

• 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?

• 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).

What's in it for me?

• Opportunity to work in a dynamic and innovative environment.
• Immediate start with potential for long-term career growth.
• Collaborate with a dedicated team of professionals in the medical device industry.
• Engage in meaningful work that impacts patient safety and healthcare advancements.
• Supportive work culture emphasizing continuous improvement and professional development.

Upon completion of waiting period consultants are eligible for:

• Medical and Prescription Drug Plans
• Dental Plan
• Vision Plan
• Health Savings Account
• Health Flexible Spending Account
• Dependent Care Flexible Spending Account
• Supplemental Life Insurance
• Short Term and Long Term Disability Insurance
• Business Travel Insurance
• 401(k), Plus Match
• Weekly Pay