Sr. NPI Engineer
Job in
Lakeville, Dakota County, Minnesota, 55044, USA
Listed on 2026-02-28
Listing for:
SciPro
Full Time
position Listed on 2026-02-28
Job specializations:
-
Engineering
Quality Engineering, Manufacturing Engineer, Medical Device Industry
Job Description & How to Apply Below
The Senior NPI Engineer leads the validation and launch of new medical device products into manufacturing. This role ensures products are ready for production, meet quality and regulatory requirements, and can be scaled efficiently. The position works closely with R&D, Operations, Quality, Supply Chain, and customers to support successful product launches.
Key Responsibilities- Lead process validations (IQ, OQ, PQ) and statistical studies
- Support pilot builds and transfer products into production
- Develop and approve validation documents
- Lead risk assessments (DFMEA, PFMEA) and control plans
- Support scale‑up activities and production readiness
- Drive root cause investigations and CAPA
- Oversee development of fixtures and validation equipment
- Train manufacturing teams on new processes
- Ensure compliance with FDA regulations and quality systems
- Bachelor’s degree in Engineering (Mechanical, Industrial, Biomedical, or related field)
- 8+ years of medical device experience (catheter experience preferred)
- Strong experience with IQ/OQ/PQ and statistics
- Knowledge of GD&T and Solid Works
- Experience working in FDA‑regulated environments
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