Design Quality Engineer

NovintiX; Raynham (MA); On-site; USD 110,000 - 150,000; Full time

Job summary

NovintiX is seeking a Design Quality Engineer to drive DHF/QMS migrations, remediation, and design transfer across R&D, Regulatory, Manufacturing, and Quality teams. You will ensure DHF/DMR/DHR alignment with ISO 13485, FDA 21 CFR 820, and EU MDR, while leading risk management, V&V, and change control efforts.

Ideal candidates hold a Biomedical/Mechanical engineering degree with 5–8 years in medical devices, and demonstrate excellent documentation and cross-functional collaboration skills.

Qualifications

• Bachelor’s or Master’s in Biomedical, Mechanical, or related engineering.
• 5–8 years of Design Quality Engineering in medical devices.
• Strong knowledge of DHF, DMR, DHR, and design controls.
• Experience with QMS migration, DHF remediation, or design transfer.
• Solid knowledge of ISO 13485, 21 CFR 820, EU MDR.
• Hands-on 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 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

Design controls

Regulatory compliance

ISO 13485 knowledge

FDA 21 CFR 820

Risk management

V&V

Change management

Audit readiness

Documentation

Cross-functional collaboration

Education

Biomedical/Mechanical/related engineering degree

Tools

eQMS

Windchill

Agile

Job description

• 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 projects.