Title: Design Quality Engineer
Location: Massachusetts
Duration: 6+ Months
Pay Rate: $48 $50/hr on W2
Type: Contract W2
Job SummarySeeking a Design Quality Engineer to support medical device development and sustaining projects, with a strong focus on product software quality. The role will support design controls, software V&V, risk management, requirements traceability, DHF documentation, and design change activities.
Key Responsibilities- Support Design Quality activities for medical device software.
- Review design inputs/outputs, software requirements, and DHF documentation.
- Review software V&V protocols, test results, and requirements-to-test traceability.
- Identify documentation, verification, and traceability gaps.
- Support risk assessments, FMEAs, and evaluation of design/software changes.
- Support change control, CAPA, quality investigations, and design transfer.
- Collaborate with R&D, Manufacturing, Regulatory, and Project Management.
Requirements- Hands-on Medical Device Software Quality/Design Assurance experience.
- Strong knowledge of Design Controls and DHF.
- Experience with Software Verification & Validation and requirements traceability.
- Experience with Risk Management, FMEA, and ISO 14971.
- Experience supporting design changes, CAPA, and design transfer.
- Working knowledge of ISO 13485 and FDA medical device requirements.