The Advanced Manufacturing Engineer initiates and leads end-to-end industrialization for new products and design changes. This includes selecting equipment, developing tooling and fixtures, conducting IQ/OQ/PQ validations, and managing site-to-site transfers in compliance with FDA QSR/cGMP and ISO 13485 standards. The role applies Design for Excellence (DFX) principles throughout product development to improve manufacturability, reliability, and serviceability, while executing equipment, automation, and labor-capacity strategies. It drives business metrics such as cost of goods, yield, takt, and line productivity using Design for Six Sigma (DFSS), Design of Experiments (DOE), and statistical process control (SPC). The engineer uses data-driven methods to resolve complex manufacturing and equipment issues in alignment with quality, compliance, and environmental, health, and safety standards. The role partners with cross-functional teams, external suppliers, and manufacturing sites to manage change, influence stakeholders, and deliver regulated product launches on time and within budget. This is an office role; office-based teams work in person at least three days per week.
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Job Type
Full-time
Career Level
Entry Level