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 integrates Design for Excellence (DFX) principles throughout product development to optimize manufacturability, reliability, and serviceability, while executing strategies for equipment, automation, and labor capacity. The engineer drives business metrics such as cost of goods (COGS), yield, takt, and line productivity using Design for Six Sigma (DFSS), Design of Experiments (DOE), and statistical process control (SPC). The role applies data-driven engineering methods to resolve complex manufacturing and equipment issues while maintaining quality, compliance, and environmental, health, and safety (EHS) alignment. It also partners with matrixed teams, external suppliers, and internal manufacturing sites to manage change 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. Candidates must reside in or within commuting distance of Colorado. US work authorization is required; visa sponsorship and relocation benefits are not available.
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Job Type
Full-time
Career Level
Entry Level