Design Quality Engineer

NovintiX; West Chester (Chester County); On-site; USD 85,000 - 120,000; Full time

Job summary

NovintiX is seeking an experienced Design Quality Engineer (5-8 years) to support a major DHF and QMS migration project. You will ensure regulatory alignment across ISO 13485, FDA 21 CFR 820, and EU MDR, reviewing design controls and maintaining complete traceability.

You will collaborate with R&D, Regulatory, Manufacturing and Quality teams to enable smooth design transfer and remediation. The role emphasizes documentation rigor, risk management, and audit readiness in a multinational setting.

Qualifications

• Bachelor's or master's degree in biomedical/mechanical engineering or related field.
• 5–8 years of design quality engineering in medical devices with ISO 13485/FDA knowledge.
• Experience with DHF, DMR, DHR, design control and QMS migration.

Responsibilities

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

Skills

Regulatory compliance

DHF knowledge

Documentation & traceability

Cross-functional collaboration

Education

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

Tools

eQMS (Agile, Windchill)

Job description

Role: Design Quality Engineer (5-8 Years Experience)

Full-Time | MedTech | Quality & Regulatory

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.

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.

KEY 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.

PREFERRED SKILLS:

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