Design Quality Engineer – MedTech (DHF/QMS Migration)

NovintiX; West Chester (Chester County); On-site; USD 110,000 - 140,000; Full time

Job summary

NovintiX is seeking an experienced Design Quality Engineer to support a major project involving DHF and QMS migration activities. You will ensure design documentation, risk files, and V&V reports meet regulatory standards and maintain complete traceability.

Collaborate with R&D, Regulatory, Manufacturing and Quality teams for design transfer, remediation, and audit readiness, with emphasis on ISO 13485, FDA 21 CFR 820, and EU MDR requirements.

Qualifications

• Bachelor’s/Master’s in Biomedical, Mechanical, or related engineering discipline.
• 5–8 years of Design Quality Engineering experience in the medical device industry.
• Strong understanding of DHF, DMR, DHR, and design control processes.
• Experience with QMS migration, DHF remediation, or design transfer.
• Solid knowledge of ISO 13485, 21 CFR 820, EU MDR.
• Hands-on experience in risk management (ISO 14971), V&V, and change management.
• Excellent documentation, analytical, and communication skills.

Responsibilities

• Execute DHF and QMS migration activities.
• Ensure design documentation, risk files, V&V reports meet regulatory and QMS standards.
• Review & approve design control documents with complete traceability.
• Support DHF remediation and document consolidation.
• Collaborate with R&D, Regulatory, Manufacturing & Quality teams for smooth design transfer.
• Identify and close gaps per ISO 13485, FDA 21 CFR 820 & EU MDR requirements.
• Support audit preparation and inspection readiness.
• Participate in change control and assess regulatory/quality impact.
• Ensure alignment with internal quality systems and regulatory expectations.

Skills

DHF & QMS migration

Regulatory compliance

V&V

Design transfer

Documentation

Education

Bachelor's or Master's in Biomedical/Mechanical Engineering

Tools

eQMS

Windchill

Six Sigma

Job description

NovintiX is seeking an experienced Design Quality Engineer to support a major project involving DHF and QMS migration activities. You will ensure design documentation, risk files, and V&V reports meet regulatory standards and maintain complete traceability.

Collaborate with R&D, Regulatory, Manufacturing and Quality teams for design transfer, remediation, and audit readiness, with emphasis on ISO 13485, FDA 21 CFR 820, and EU MDR requirements.