Medical Device Design Quality Engineer

ManpowerGroup Global, Inc.; Pittsburgh (Allegheny County); On-site; USD 106,020,000 - 120,347,000; Full time

Benefits offered by this job

Medical Plan

Dental Plan

Vision Plan

Health Savings Account

Health Flexible Spending Account

Dependent Care Flexible Spending

Life Insurance

Job summary

ManpowerGroup Global, Inc. in Pittsburgh, PA seeks a Medical Device Design Quality Engineer to support product development and manufacturing within the Quality Assurance team. The role emphasizes design control, risk management, verification/validation planning, and design transfer readiness.

You will lead DFMEA activities, review protocols, and manage NCs/CAPAs to ensure compliance with ISO 13485, FDA QSR, and EU MDR.

Qualifications

• 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 ISO 14971.

Responsibilities

• Support design quality activities throughout new product development including design reviews and design transfer readiness.
• Lead DFMEA and risk assessments to identify and mitigate design/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 requirements are translated into manufacturing, inspection, supplier, validation, and release deliverables.
• Manage and drive timely resolution of nonconformances (NCs) and CAPAs.

Skills

Design Quality

DFMEA

Risk management

CAPA

Minitab

8D DMAIC

Education

Bachelor's degree in Engineering/Quality

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