New

Development Quality Engineer II

Spectraforce Technologies

Jun 02, 2025
Title: Development Quality Engineer II Duration: 06 months Location: Plymouth, MN 55442 What You'll Work On Execute Design Verification/Validation Strategies with emphasis on Technical analysis of requirements, specifications, and control strategy Alignment of design outputs to production and process controls Proper verification techniques including inspection, demonstration, test, etc. Lead design characterization activities for development projects Support design test and inspection method development, and lead method validation activities. Qualifications Bachelor level degree in Engineering or Technical Field; advanced degree / Biomedical Engineering / Electrical Engineering / Computer Science preferred. 3-5+ years Engineering experience with new product development Experience in supplier controls, critical quality attributes, and tracing design outputs to implemented supplier processes. Working knowledge on design verification and design validation techniques. Working knowledge of applied statistics, sampling strategies, and design of experiments, including statistical software tools such as Minitab. Strong organizational and follow-up skills, as well as attention to detail Ability to collaborate on-site on a regular basis. Knowledge of FDA, IEC 60601, GMP, ISO 13485, and ISO 14971 Prior medical device experience preferred