What are the responsibilities and job description for the Development Quality Engineer II position at Intellectt Inc?
Role: Development Quality Engineer II
Location: St. Paul, MN - 55117
Duration: 12 Months (W2) – Possible Extension
Shift: 8 AM – 5 PM
Role Overview
We are seeking a Development Quality Engineer II to join the Structural Heart division, focusing on catheter-based technology used for aortic valve implants. The engineer will play a key role in test method development, inspection processes, and process validation to ensure product performance and compliance with regulatory standards.
Key Responsibilities
- Support test method development and inspection processes
- Conduct process validation, including Operational Qualification (OQ), Process Qualification (PQ), and Product Performance Qualification
- Assist in design verification testing and planning
- Perform equipment qualifications
- Generate and review document change orders
- Troubleshoot and resolve issues on the manufacturing floor
- Maintain Device History Files (DHF)
- Collaborate with Program Management, R&D, and Supply Chain teams
- Support and review CAPA investigations to ensure compliance with FDA, ISO, and EU/US regulations
Required Skills & Experience
- Bachelor’s degree in Mechanical Engineering or Biomedical Engineering
- 2–3 years of experience in medical device quality engineering with catheter-based technologies in the Structural Heart space
- Experience with test method development, process categorization, and validation
- Strong verbal and written communication skills
- Prior experience at Abbott is a plus
Candidate Criteria
- Medical device experience is required
- Catheter-related quality experience within Structural Heart is highly preferred
