Senior Design Quality Engineer – DHF/QMS Migration Expert

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

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.