Responsibilities: Drive Lean improvements to increase yield, efficiency, and throughput.Lead root cause investigations and CAPA implementation activities.Support process transfer and scale-up from development into production.Execute process qualification (PQ) and assess production readiness.Develop and improve SOPs, work instructions, and process documentation.Collaborate with customers, Quality, Operations, and R&D while ensuring ISO 13485/GMP compliance.Education & Qualifications: Bachelor's degree in Mechanical, Manufacturing, Industrial Engineering, or related field.1–4 years of manufacturing or process engineering experience.Background in regulated industries, preferably medical devices.Experience applying Lean manufacturing principles and continuous improvement.Strong troubleshooting, root cause analysis, and communication skills.Familiarity with cleanroom environments and production support.Knowledge of process validation, GMP, ISO 13485, and CAD/CAM tools preferred.#J-18808-Ljbffr
| Location | Minneapolis, MN |