Design Quality Engineer

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 a global Engineering & Digital Transformation company supporting leading organisations in MedTech, Life Sciences, Healthcare, and Advanced Manufacturing across the US, Ireland, and Europe. We partner with clients to accelerate innovation and ensure compliance in highly regulated environments.

About the Role

We are looking for an experienced Design Quality Engineer to support a major project involving Design History File (DHF) and Quality Management System (QMS) migration activities.

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.

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.

Required Skills

• Experience with eQMS (Agile, Windchill, etc.).
• Six Sigma Green Belt or similar.
• Experience in multi‑site/global product lifecycle projects.