Medical Device Design Quality Engineer
About the role
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).
Requirements
- 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)
Benefits
- 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
Pay
$37–$42/hour on W2
Schedule
Onsite in Pittsburgh, PA