Design Quality Engineer

Synstack Technologies; New York (NY); On-site; USD 100,000 - 140,000; Full time

Job summary

Synstack Technologies is seeking an experienced Design Quality Engineer to support DHF and QMS migration activities for a major medical device project. You will ensure design documentation, risk files, V&V reports meet regulatory and QMS standards.

You will collaborate with R&D, Regulatory, Manufacturing and Quality teams to drive design transfer, close gaps per ISO 13485, FDA 21 CFR 820 and EU MDR requirements, and support audit readiness.

Qualifications

• Bachelor’s or Master’s in Biomedical, Mechanical, or related engineering field.
• 5–8 years of Design Quality Engineering in medical devices.
• Strong knowledge of DHF/DMR/DHR and design control processes.
• Experience with QMS migration and design transfer.

Responsibilities

• Execute DHF and QMS migration activities.
• Ensure design docs, risk files, V&V reports meet 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.

Skills

DHF/DMR/DHR

QMS migration

ISO 13485

Regulatory liaison

Education

Bachelor’s/Master in Biomedical or Mechanical

Tools

eQMS (Agile)

Windchill

Job description

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.