What are the responsibilities and job description for the Design Assurance Engineer position at Invent Staffing?
Job Title: Design Assurance Engineer
Location: Brooklyn Park, MN 100% onsite
Length: 12 months
Responsibilities:
- Serve as quality representative for engineering projects.
- Ensure compliance with Quality System Regulations (QSR) for product development and changes.
- Lead NCMR and CAPA investigations, troubleshooting manufacturing issues.
- Collaborate with suppliers on NCMRs and CAPAs.
- Participate in cross-functional teams for product risk management, DFMEA, PFMEA, and V&V testing.
- Assist in Design and Process Verification/Validation, provide statistical analysis guidance.
- Support Design Reviews, FMEA Reviews, and complaint investigations.
Requirements:
- Medical Device experience (****Catheter experience preferred).
- Expertise in Quality Engineering / Design Assurance.
- Knowledge of 21 CFR 820, ISO 13485, ISO 14971.
- Experience with NCMRs, CAPAs, Risk Management, DFMEA, PFMEA, V&V.
