What are the responsibilities and job description for the Development Quality Engineer position at Intellectt Inc?
Role: Development Quality Engineer II
Location: St. Paul, MN - 55117
Duration: 12 Months on W2 (possible extension)
Shift Timings: 8 AM to 5 PM
Skills Looking For:
- Supporting development efforts from a Development Quality perspective for a novel transcatheter aortic implantation (TAVI) system
- Support Test Method and Inspection Method development.
- Planning and execution of Design Verification and Validation.
- Root-Cause Analysis exp, CAPA.
- Hands-on support for development manufacturing and testing activities.
- Experience with Minitab is nice to have.
- Medical device experience with structural heart delivery system development or manufacturing or other intracardiac catheter device development is strongly preferred.
- Familiar with 21 CFR Part 820, ISO 13485, ISO 14971, EUMDR, and MDSAP.
- Self-motivated, driven, and proactive.
- Must have strong communication skills and ability to work cross-functionally.
Education and Experience:
- Minimum bbachelor’s degree with 2 years of relevant experience.
Top Skills:
- Operations Quality or Development Quality experience in the medical device industry.
- Experience in Design Verification & Validation activities and test method activities.
- Minitab experience
Interview Process:
- Phone Screening followed by video interview.
