What are the responsibilities and job description for the Research And Development Specialist position at Intellectt Inc?
Development Quality Engineer
Location: St. Paul, MN 55117
Duration: 12 Months (W2 Contract)
Join the client’s Structural Heart team as a Development Quality Engineer, where your work will directly contribute to the development of cutting-edge Transcatheter Aortic Valve Implantation (TAVI) systems—improving patient lives around the world.
Position Summary:
You’ll ensure new or modified products comply with regulatory and quality system requirements, working cross-functionally to support new product development, risk management, design validation, and manufacturing process development. This role is pivotal in protecting patient safety while aligning with business needs.
Key Responsibilities:
- Drive on-time completion of Development Quality deliverables
- Lead Risk Management and Failure Mode Effects Analysis (FMEA) activities
- Support Test Method Validation, Design Verification, and Process Validation
- Oversee Document Change Orders and CAPAs
- Collaborate across teams (R&D, Program Mgmt., Process Development)
- Participate in cleanroom product builds for both development & commercial needs
- Ensure audit readiness and support compliance efforts
- Write and revise SOPs and quality documentation
Required Qualifications:
- Bachelor’s degree in Engineering or related discipline
- 2 years of engineering experience with proven use of quality tools
- Strong communication, problem-solving, and organizational skills
- Ability to manage multiple priorities in a dynamic, matrixed environment
- Willingness to travel occasionally (<5%)
Preferred Qualifications:
- Medical device experience—especially with structural heart or intracardiac catheter systems
- Familiarity with 21 CFR Part 820, ISO 13485, ISO 14971, EUMDR, MDSAP
- Experience with MiniTab is a plus
